Data on Orthopaedic Implants Kept in Notebooks
Anuška Delić, Maja Čakarić, Oštro editorial board
In a month, on 1 January 2019, the National Arthroplasty Registry – which contains data on all artificial hips, knees, shoulders, and other joints implanted in Slovenian patients – will be up and running. But it will not contain any data. Most Slovenian hospitals keep it on paper.
“Sometimes I joke that I’ll just let them creak until I kick the bucket,” says Slavko Vizovišek, a retired journalist, about his artificial hips. They are the loudest in the morning. It gets better when he warms up a little.
He is not too keen to go into surgery and have two new hips implanted. He decided that things will simply stay as they are. “If I walk around town with someone, they think I have hobnailed boots,” he quips.
He first started feeling pain in his left hip in the middle of the 1990s. Back then, five years before turning fifty, he was still too young for a joint replacement. More than a decade passed before he underwent a left hip replacement in March 2006. At that time he started feeling pain in his right hip too. He had it replaced with an artificial one by the end of the same year.
“At first, the hip caused me pain while I was walking, but then it became my constant companion and it was really excruciating. The procedure was a relief. After 13 years of pain and not being able to walk normally any longer, I could go hiking again,” he said.
He said that he had not been told what brand of hip he received, learning only that it was made of metal, plastic and ceramics, and that “it is the best they have.”
He trusted the doctors who operated on him in the Valdoltra Orthopaedic Hospital. “It was nothing like what I have seen before. The organisation was excellent and they respect appointment times,” he said.
When, ten years after the procedure, Vizovišek’s hips started creaking, he went back in for a check-up: “A young doctor looked through the papers and said that he couldn’t believe I let them implant it in me. He knew that this prosthesis was no good. He knew that there was something wrong with these prostheses since 2008. But they implanted them in me two years before that.”
In the digital year of 2002
Vizovišek was lucky. The Valdoltra Orthopaedic Hospital is the only hospital in Slovenia that keeps exemplary records of the implants its doctors use, in this case artificial hips and knees.
According to the data from the Health Insurance Institute of Slovenia (ZZZS), last year Valdoltra performed just under a quarter of all hip replacements and a little less than a third of all knee replacements in the country. On the first day of 2019, the hopsital will begin administering the National Arthroplasty Registry and, at the end of 2019, it will celebrate its 110th anniversary.
Despite this respectable age, Valdoltra keeps up with technological changes — which is something we cannot say for other Slovenian hospitals. Valdoltra started to digitalize its data on hip and knee implants already in the late 1990s and developed its own internal arthroplasty registry as early as in 2002.
As hospital administrators explained to Oštro, they introduced the registry in order to ensure the traceability of implants, as required by law. Besides, it was also a business decision to ensure “control over the cost-effectiveness of our operations”. The Valdoltra registry also proved to be a good foundation for conducting clinical studies. Today the hospital is a member of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT).
The Valdoltra registry, at least the portion we had access to under the Access to Public Information Act, is rich with data. It contains records of all the important details of every surgery, whether the initial implantation of a prosthesis or a revision procedure to replace a malfunctioning implant.
The registry contains as many as 54 categories of data on hip revision procedures, from the side of the body of surgical treatment to names of hospitals where patients were first implanted with their faulty prosthesis. In three quarters of revision procedures, Valdoltra exchanging prostheses it had implanted earlier, while the University Medical Centre Ljubljana (UKC Ljubljana) performed most of the revision interventions among the remaining 25 percent.
Valdoltra’s own statistics show that the vast majority of their hip and knee procedures had no complications. But when we tried to informally verify these numbers at the hospital, an employee said: “Garbage in, garbage out – these are not necessarily accurate figures.”
Hip replacements on the rise
The number of all hip procedures in this hospital has been steadily rising since 1998. Today, it is over 80 percent higher than that year’s total. According to professional estimates, on average about 12 percent of hip and around 10 percent of knee implants must eventually be replaced.
The reasons for revision procedures depend on patient’s age, activities, and other factors which can affect durability of prosthesis.
According to Valdoltra’s data, which spans nearly four and a half years, adverse events were mostly – slightly less than one fifth of cases – caused by “acetabular cup loosening” which means that the cup in which an artificial thigh bone “sits” got loose. In just under a fifth of cases the cause was the loosening of an artificial femoral stem.
In just 10 percent of cases, “periprosthetic femoral fractures” or, in simpler terms, femur fracture, occurred, making this the third-most common reason for a revision operation.
Two years ago, the Slovenian media widely reported two cases of artificial hip fractures. Both patients had received the Profemur Z implant, which is manufactured by Wright Medical Technologies. This prosthesis used to be produced by Italian Cremascoli, and our sources explained that their products enjoyed a strong reputation. The first issues occurred, they said, when Wright Medical Technologies took over the company and changed the design.
Valdoltra stopped inserting this hip implant back in 2012 — a conclusion we were able to obtain because of the hospital’s orderly record-keeping.
Because the U.S. Food and Drug Administration (FDA) also keeps orderly records, we could gain access to data on adverse events and recalls involving various medical devices in the U.S. by searching the Manufacturer and User Facility Device Experience Database (MAUDE).
There are thousands of adverse events cases in the MAUDE database involving Profemur Z hips.
This database was put to good use by 252 journalists from around the world who, together with the International Consortium of Investigative Journalists (ICIJ), spent a year investigating the medical device industry. The data also turned out to be useful also for Oštro.
In the analogue year of 2018
Slovenia does not have a public registry of medical devices where patients, doctors, academics, or the general public can obtain credible information on adverse events involving devices which they use, study or implant. Patients are left to their own initiative.
When Slavko Vizovišek, the former Večer daily journalist whose artificial hips are creaking, was in doubt, he consulted an orthopaedist acquaintance. After looking at the scans, he said that everything seemed in order and that he did not need an operation, also because he was not in pain.
The introduction of the National Arthroplasty Registry, which was announced several years ago, will not change anything in the short-term as far as public access to health data is concerned. All the hospitals in Slovenia that implant various joint prostheses keep their implant data in notebooks.
Slovenian hospitals have been submitting forms on implanted prosthesis to The National Institute of Public Health (NIJZ) since 2010. But NIJZ did not digitize the forms, keeping them on paper for eight years.
The agency said that it did not digitize them because the Healthcare Databases Act did not provide for it to maintain a collection of such data. Incidentally, the Valdoltra registry was also not envisaged in this Act, but it was still developed and maintained for many years for its own use.
Speaking with Oštro, NIJZ first claimed that all Slovenian hospitals have digitized data on implanted prostheses. When we informed them of our own findings – that the opposite was true –, they referred us back to Valdoltra.
For more than a year, Oštro journalists have been trying to collect data on orthopaedic implants that the Medical Devices Act requires hospitals to keep. First, we asked for this data in electronic form from all Slovenian hospitals, but admitted defeat when about half of them let us know that they only had it on paper.
We then asked for implant data maintained by hospitals’ purchasing departments, receiving it from some hospitals and being ignored by others. We will be in touch with the latter by filing complaints in line with the Access to Public Information Act.
Among the hospitals that did not send any data was the general hospital in Ptuj, which maintains it only on paper. UKC Ljubljana cited similar reasons, thumped their chest and even authoritatively decreeing that this data was not in the public interest.
In the end, the largest Slovenian health center in Ljubljana awoke from its slumber and sent us the data on hip and knee prostheses from 2010 onward, maintained by its Division for Surgery.
But this was not data on the use of prostheses. UKC Ljubljana only keeps records of purchased materials and equipment. Worse, sources familiar with the inner workings of the hospital say that UKC Ljubljana regards medical devices as “used” the moment they are sent to one of its clinics.
In fact, each clinic has its own record-keeping system, and these systems are not always compatible. Officially, the hospital did not want to unambiguously confirm they only know which medical devices have been purchased and not which ones have actually been implanted.
“In this regard, we wish to explain that the data on actual use of purchased medical devices is available but that the software is not configured for exporting the data in the way you requested. If we would want to export such data we would need to create a new database and that would incur additional cost,” a hospital representative wrote.
Data on inserted implants gathered from Valdoltra, UKC Ljubljana, UKC Maribor, and general hospitals in Celje, Jesenice, and Novo mesto revealed that more than half of the endoprosthetics market in Slovenia is controlled by four large manufacturers: Zimmer Biomet, Johnson & Johnson, Stryker, and Lima.
Until the middle of 2015, Zimmer and Biomet were two separate companies. Then Zimmer bought Biomet for around $14 billion (slightly more than €12 billion), making the new firm a leading producer of orthopaedic devices and prostheses.
Its hips are not flawless, though. The company’s name shows up five times in safety notices on adverse events involving orthopaedic implants received by the Agency for Medicinal Products and Medical Devices (JAZMP) between 2015 and 2018.
Before it was purchased by Zimmer, Biomet produced a hip prosthesis called Durom-Metasul LDH. German doctors began implanting it in 2003, but six years later the first information about serious issues with the implant started to surface. In 2010, lawsuits began to pile up and, in 2012, Zimmer took the product off the market. By then, 37,000 Durom-Metasul LDH implants had been inserted in patients throughout Europe.
A source in one of Slovenian hospitals well informed about the purchasing possibilities in Europe for small markets like the Slovenian one, explained that staff try to choose the best prostheses for their patients among those available to them. A medical device may be available on the European market, but manufacturers decide whether it will also be sold in Slovenia.
A new era or only a disguise?
“The national registry of endoprosthetics is very important for Slovenian orthopedics,” wrote Valdoltra, adding that the hospital has pursued this goal for several years. But the register will have to be in operation for a few years, before its data will become useful for analysis.
Slovenia’s National Institute of Public Health (NIJZ) confirmed that it has already transferred to Valdoltra the implant forms that had been gathering dust there since 2010. Because NIJZ does not know how many forms had been gathered over eight years, we asked for a descriptive explanation.
“Altogether there are 25 boxes. Dimensions of half of them are 30x50x10cm while the other half are a little smaller, around 20x40x10cm.,” they replied.
After several emails the agency also said that, with the exception of Valdoltra, Slovenian hospitals do not have digitalized data on hip and knee implants. “Because the forms containing the data were computer-printed, we concluded that they involve a digital form of input. We received the same information from Valdoltra and we did not check this with individual hospitals.”
Since 2010, “with every passing year,” the agency expected new rules to be put in place which would allow them to hand the paper forms to “a new manager.” But this did not happen until a few days ago, when they handed them over to Valdoltra. Although the first official working group in charge of recasting the Healthcare Databases Act was established seven years ago, the law did not envision the registry of artroplasty until it was changed in April this year.
Valdoltra confirmed receiving the forms a few weeks ago. The hospital will use them to create an overview of all prostheses currently in use in Slovenia, which will in turn help finalize the internet version of the National Arthroplasty Registry. This will mean extra costs for which “Valdoltra was not allocated any resources by the ZZZS or from the state budget yet”.
A month before the launch of National Arthroplasty Registry, the Ministry of Health has no information about this: “We do not have an estimate of the costs.”
The Agency for Medicinal Products and Medical Devices did not reply to questions about the National Arthroplasty Registry, or the costs.
The Public Health Institute estimated that it would cost around €30,000 to develop the application intended for collecting, storing, and reviewing the hip implant data and another €30,000 to collect and monitor it.
It appears that no costs will be incurred for now. “For the time being, we will transfer the implants’ data into our database by using existing personnel,” explained a public relations officer at Valdoltra.
No one knows how much it cost the taxpayers to maintain a futile data collection system for eight years.