ZIMMER CHARACTER KNEE
After less than 3 years available on the market, the Persona knee implant by Zimmer has been recalled by Zimmer because it may be prone to acute pain, loosening, and the need for an early revisioning operation.
ZIMMER RECALLS PERSONA KNEE IMPLANT
A notice was issued by the FDA on March 12 for a Class II Recall for all loads and sizes of the Zimmer Part Trabecular Metal Tibial Plate knee implant. Based on the bureau, 11,658 devices are included in the recall.
“Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution,” the FDA announced.
Whenever a product has the potential for short term or medically unrepairable health results, the FDA issues a Class II Recall. However the issues connected with the Persona can continue to create numerous problems.
ZIMMER RECEIVES HIGH VARIETY OF CRITICISMS
The apparatus-manufacturing company has received an unusually large number of grievances involving early loosening of the implant and unwanted impression. The manufacturer has determined approximately 6 complaints per 1,000 devices planted, which is higher than the speed of complaints for similar implants.
About 36% of the complaints included patients who had radiolucent lines, symptomatic issues, and needed revision surgery due to early loosening of the implant. Zimmer warned:
“Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.”
The Persona knee implant manufactured by Zimmer was recalled due to “an increase in complaints of loosening and radiolucent lines.”
Radiolucent lines are dark lines which can be seen on X-rays. They are a symptom of a poorly- knee implant that is fixated. They are also related to failure and premature loosening of the acetabular component of the knee implant.
Radiolucent lines can cause a number of difficulties. Joint fluid, tissue and implant-wear debris may lodge in the cracks, resulting in bone damage called osteolysis, which is an early indicator of implant failure. Loose implants can cause severe pain, swelling and tissue and bone damage.
Radiolucent lines additionally indicate to a surgeon the patient may require revision surgery o correct the problem and generally must replace the implant.
WHO’S IMPACTED BY THE ZIMMER KNEE RECALL?
The recall includes nearly 11,700 implants in all lots and sizes C-J. They were sold starting in November 2013 and ending in January 2015 throughout America and in other countries.
ZIMMER’S HISTORY WITH OTHER ISSUES AND PRODUCT RECALLS
Zimmer produces a number of implants its popular NexGen and High Flex Knees and various hip implant parts and is one of the biggest apparatus makers on the planet.
In 2008, the firm briefly recalled the Durom Cup hip component. Based on the business, the hip implant failed early because surgeons desired more training. But one of Zimmer’s own paid advisors, Dr. Lawrence Dorr, found that the implant’s circular cutting surface on the border of the implant prevented it from staying in place and the fixation surface wasn’t acceptable.
The firm’s flagship knee apparatus, the Nex Gen and High Flex were promoted to active patients who needed greater flexibility in the knee. However, the FDA received reports of loosening and device failure.
In 2010, Zimmer recalled almost 70,000 of MIS Tibial components because of loosening. Subsequently, in 2014, Zimmer recalled 40,000 NexGen Knee models because screws were defective and could lead to loosening and failure.
ZIMMER PART KNEE LITIGATIONS
Zimmer promoted the Character knee as the “ most clinically successful knee replacement more personalized Instead, a lot of people who were implanted with this device have experienced needed revision surgery or serious problems.
Contact our attorneys if a loved one or you experienced any of the following difficulties:
- Knee pain
- Loosening of the knee replacement
- Inferior fixation
- Reduced mobility
- Revision surgery
DO I HAVE A ZIMMER CHARACTER SUIT?
The Feather Law Group is currently accepting Zimmer Persona injury cases. If you or somebody you know was injured by a faulty knee replacement, you should contact our lawyers immediately for a free case consultation. We’d feel privileged to work with you. For a free consultation and more information regarding your legal choices, please phone us at 1-866-FEATHER. If you prefer, please complete the online form and a customer relations representative will be in contact with you promptly.