Catalog Number 623-00-36D |
Device Problems
Crack (1135); Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 02/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.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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Surgeon requesting wear data on explanted poly.There was no issue with the poly, he is only curious about wear rates.Product explanted during revision hip surgery.
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Event Description
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Surgeon requesting wear data on explanted poly.There was no issue with the poly, he is only curious about wear rates.Product explanted during revision hip surgery.Rep reported that reason for revision was "instability, patient soft tissue laxity required a more constrained insert." only the insert was revised.
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Manufacturer Narrative
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Additional information: lot #, expiration date; pma/510(k)#; manufacturing date.An event regarding pain and instability involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: the product was returned damaged.Visual inspection of the product shows multiple scratches and small dents on all surfaces.There is a crack on the inside surface of the liner and some discoloration on the outer surface.Material analysis observed damage on device consistent with in-service use and explantation damage.Clinician review: not performed as no medical records and/or x-rays were provided.Product history review: all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event could not be confirmed nor the root cause of the reported event determined due to no medical records received.Further information such as primary and revision operative reports, dated x-rays and past/clinical medical history are needed for completion of the assessment.No further investigation 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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Search Alerts/Recalls
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