STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Model Number 625-0T-28D |
Device Problems
Degraded (1153); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 01/24/2023 |
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.Device not returned.
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Event Description
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The following was reported: a surgery to remove and replace the ceramic liner was performed based on the ct data, which appeared to be damaged liner.A hard object was found during the procedure.Can you please investigate whether the alumina ceramic liner is damaged and what the hard object is? reason for revision was due to pain.
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Manufacturer Narrative
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Reported event: an event regarding damage involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with explantation.No wear was observed on the device.No further surface discrepancies were observed.-clinician review: a review of medical records with a clinical consultant indicated " conclusion/assessment: by report a revision surgery was performed based on a ct scan that seemed to indicate bearing fracture.As noted in the narrative, the ct image appeared to show debris or fragments of some kind in the joint.The radiographic density of the fragments seem more than the head.The origin of the debris, if present, is unclear.No conclusions may be drawn from the x-rays or report without additional medical information.Event confirmation: the event cannot be confirmed without additional medical information.Root cause: a root cause cannot be ascertained without additional medical information." -product history review: review of the device history records indicate the devices were manufactured and accepted into final stock on 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.Visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with explantation.No wear was observed on the device.No further surface discrepancies were observed.A review of medical records with a clinical consultant indicated " conclusion/assessment: by report a revision surgery was performed based on a ct scan that seemed to indicate bearing fracture.As noted in the narrative, the ct image appeared to show debris or fragments of some kind in the joint.The radiographic density of the fragments seem more than the head.The origin of the debris, if present, is unclear.No conclusions may be drawn from the x-rays or report without additional medical information.Event confirmation: the event cannot be confirmed without additional medical information.Root cause: a root cause cannot be ascertained without additional medical information." 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 following was reported: a surgery to remove and replace the ceramic liner was performed based on the ct data, which appeared to be damaged liner.A hard object was found during the procedure.Can you please investigate whether the alumina ceramic liner is damaged and what the hard object is? reason for revision was due to pain.
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Search Alerts/Recalls
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