| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00199-1 |
| Product Name/Description |
Persona Trabecular Metal Tibial Plate, all sizes
Part Numbers:
42-5300-064-01, 42-5300-067-01, 42-5300-071-01, 42-5300-075-01, 42-5300-079-01, 42-5300-083-01, 42-5300-088-01, 42-5300-064-02, 42-5300-067-02, 42-5300-071-02, 42-5300-075-02, 42-5300-079-02, 42-5300-083-02 & 42-5300-088-02
ARTG number: 222393 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer is initiating a hazard alert for the Persona Trabecular Metal™ Tibial Plate as the current complaint rate (0.61%) for radiolucent lines and loosening is higher than Zimmer’s expectations and experience based on Zimmer’s similar devices
Out of the 0.61% complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. 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. There have been no revisions or reports of radiolucency lines or loosening in Australia. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised to follow-up with patients implanted with Persona Trabecular Metal Tibial Plate and also continue their normal post-operative follow -up routine.
For additional information please see https://www.tga.gov.au/alert/persona-trabecular-metal-tibial-plate-used-knee-replacements . This action has been closed-out on 18/07/2016, |
| Contact Information |
02 9483 5400 - Zimmer |