STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problems
Unstable (1667); Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); Joint Laxity (4526)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.Device not returned.
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Event Description
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A patient specific prescription form was received for the patient's left distal femur with reason for revision noted: "femoral stem instability, max extension.".
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Event Description
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A patient specific prescription form was received for the patient's left distal femur with reason for revision noted: "femoral stem instability, max extension.".
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Manufacturer Narrative
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Reported event: an event regarding infection involving a jts, distal femur replacement, 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 jts distal femoral replacement which was inserted in 2018.The surgeon reported femoral stem instability and maximum extension.The ct image provided shows thick radiolucent line between the femoral stem and bone and bone remodelling near the resection which could indicate instability of the stem.The femoral component has been extended by 41mm which hasn't reached to its maximum capacity of 50mm, however, the surgeon usually will conduct another extension before revising it.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 12 feb 2018 with no reported discrepancies.Complaint history review: there have been no other events.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, 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.
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