STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 502-03-56E |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 06/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's left hip was revised due to shell loosening.The shell, head, and liner were revised.Rep confirmed that there are no allegations against the revised head and liner.
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Manufacturer Narrative
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Reported event: an event regarding acetabular shell loosening involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection of the shell show bone and tissue residue consistent with being implanted for a period of time.A portion of the torx head was returned separated from the shell and screw dents noted on the inside portion of the shell.-clinician review: no medical records were received for review with a clinical consultant.-device 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.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as pre- and post-operative x-rays, primary 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 become 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 due to shell loosening.The shell, head, and liner were revised.Rep confirmed that there are no allegations against the revised head and liner.
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Search Alerts/Recalls
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