Model Number 6720-0635 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 07/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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In email chains provided reporting a damaged instrument, there are statements that the device was being used in the revision of an accolade 2 "permanent" stem.The statement says that the stem could not be removed with the reported device.No apparent information at this time for the reason for revision or how the revision was carried out.
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Manufacturer Narrative
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Reported event: an event regarding dislocation involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned. -clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the event itself, or the exact cause of the event could not be confirmed as insufficient information was provided.Additional information including operative 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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Event Description
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In email chains provided reporting a damaged instrument, there are statements that the device was being used in the revision of an accolade 2 "permanent" stem.The statement says that the stem could not be removed with the reported device.No apparent information at this time for the reason for revision or how the revision was carried out."multi-recurrent dislocation the reason of the revision is a change of the femoral stem.".
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Search Alerts/Recalls
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