Catalog Number 502-03-56E |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 10/18/2023 |
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.
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Event Description
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The cup was implanted in the patient's right hip on (b)(6) 2014.Loosening of the cup was found and revision surgery to change the cup was performed on (b)(6) 2023.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has damage consistent with time spent implanted and damage consistent with explantation.There is nothing further remarkable to note.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the shell.Visual inspection of the returned device indicated that the device has damage consistent with time spent implanted and damage consistent with explantation.There is nothing further remarkable to note.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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The cup was implanted in the patient's right hip on (b)(6) 2014.Loosening of the cup was found and revision surgery to change the cup was performed on (b)(6) 2023.
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Search Alerts/Recalls
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