STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC, PROXIMAL TIBIAL REPLACEMENT - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number UNK_STM |
Device Problems
Unstable (1667); Naturally Worn (2988)
|
Patient Problem
Joint Laxity (4526)
|
Event Date 01/05/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
|
|
Event Description
|
Email received from surgeon: ".Needs rebushing and patella resurfacing." for the patient's custom made right proximal tibial replacement.Noted on a patient specific implant request form: "wear/ instability".
|
|
Manufacturer Narrative
|
Reported event: an event regarding rebushing involving a patient specific, proximal tibial, axle was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for patient specific proximal tibial replacement which was inserted on (b)(6) 2005.The surgeon requested a rebushing of the knee.The x-ray images provided showed that the femoral and tibial stems were in good alignment and fixation.There was no disengagement of the knee bearing components.However, the complete knee joint in front view of the x-ray was missing which may affect the review.Therefore, the radiographic review cannot confirm the clinical request but considering the implant was in situ over 17 years, normal wear and tear of the knee bearing components are expected.Thus, the clinical request for rebushing can be supported.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes, operative reports additional x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
|
|
Event Description
|
Email received from surgeon: ".Needs rebushing and patella resurfacing." for the patient's custom made right proximal tibial replacement.Noted on a patient specific implant request form: "wear/ instability".
|
|
Search Alerts/Recalls
|
|
|