Corrected data: d1.Additional manufacturer narrative: reported event: an event regarding loosening involving a jts, distal femoral replacement, tibial 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 on 06jan2011.The surgeon reported loosening of the tibial stem.The images provided show that the tibial stem is too small now left a gap between the tibial stem and bone.The original tibial stem was under passive fixation and become too small and loose after ten years due to growth of the bone.Therefore, this 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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