STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC, PROXIMAL TIBIAL REPLACEMENT, FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER AND
|
Back to Search Results |
|
Catalog Number UNK_STM |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
|
Patient Problem
Inadequate Osseointegration (2646)
|
Event Date 09/26/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.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.
|
|
Event Description
|
As reported, "revision of loose smiles knee to dfepr".
|
|
Manufacturer Narrative
|
Correction: device updated to femoral stem as opposed to femoral component.Reported event: an event regarding loosening involving patient specific, proximal tibial, femoral stem was reported.The event was confirmed by x ray review.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, the date of insertion was unknown.The surgeon reported loosening of the femoral stem.The ct image provided shows massive radiolucency along the femoral stem with segmented cement mantle which indicates loosening of the stem.The femoral bone has undergone severe remodelling, especially near the resection.There are osteolytic lesion and erosion of the bone.Therefore, the radiographic review can confirm the clinical report and reason for revision.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 operative reports, pathology reports, progress notes, 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
|
As reported, "revision of loose smiles knee to dfepr".
|
|
Search Alerts/Recalls
|
|
|