Catalog Number 6721-0635 |
Device Problems
Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Joint Dislocation (2374)
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Event Date 07/14/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
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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.H3 other text : device not returned to the manufacturer.
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Manufacturer Narrative
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An event regarding dislocation involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicates some minor damage consistent with implantation/explantation attempt.Nothing else was observed.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 disassociation of the ceramic head from the adm poly liner and dislocation of the adm poly liner from the mdm metal liner.Visual inspection of the returned devices indicated that the head and liner were damaged from the disassociation/dislocation event as well as explantation.The stem appeared unremarkable.The metal mdm liner was not revised.Further information such as 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.It was reported that the stem was also revised to add version to the hip construct; it is likely that the choice of stem implant contributed to the construct failure 3 days post-operative.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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It was reported that the patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
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Search Alerts/Recalls
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