STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR - CIRCLIP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_STM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding rebushing involving a patient specific, distal femoral replacement, circlip, was reported.The event was 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 distal femoral replacement which was inserted on (b)(6) 2000.The surgeon reported bush bearing failure.The ct image provided shows that the femoral component is in line with the tibial component.However, the circlip was backed out laterally which indicating that the knee bushing fixation was disengaged.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, progress notes, 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.
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Event Description
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A prescription form has been received for a 'revision due to bush bearing failure'.Update 17feb22: the clinical consultant reviewed the images provided and stated " [.] the circlip was backed out laterally which indicating that the knee bushing fixation was disengaged".
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Manufacturer Narrative
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Reported event: an event regarding rebushing involving a patient specific, distal femoral replacement, circlip, was reported.The event was 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 distal femoral replacement which was inserted on (b)(6) 2000.The surgeon reported bush bearing failure.The ct image provided shows that the femoral component is in line with the tibial component.However, the circlip was backed out laterally which indicating that the knee bushing fixation was disengaged.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, progress notes, 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.
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Event Description
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A prescription form has been received for a 'revision due to bush bearing failure'.Update 17feb2022: the clinical consultant reviewed the images provided and stated " [.] the circlip was backed out laterally which indicating that the knee bushing fixation was disengaged".
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