STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 07/12/2022 |
Event Type
Injury
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Event Description
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As reported: "i worked with dr.In surgery yesterday and she informed me of this patient has a loose femoral stem.She needs to revise the implant in situ." right side distal femur jts.
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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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As reported: "i worked with dr.In surgery yesterday and she informed me of this patient has a loose femoral stem.She needs to revise the implant in situ." right side distal femur jts.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a jts, distal femoral replacement 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 on (b)(6) 2021.The surgeon reported loose femoral stem.The x-ray images provided shows fine radiolucent line mainly between the cement mantle and bone.There are some resorptions and remodelling of the bone near the resection.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.
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