Catalog Number UNK_JR |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problems
Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 05/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported through the submission of a revision usage sheet that the patient's hip was revised.A restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner were implanted.Update: trunnion on the existing stem had failed and broken off.
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Manufacturer Narrative
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An event regarding crack/fracture involving an unknown stem was reported.The event for disassociation was confirmed through medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: the x-ray provided demonstrates a pressfit tha.The trunnion has fractured and the head has dissociated.While the event depicted in the x-ray would require revision surgery no information was provided that would confirm that this surgery did occur.The root cause of the trunnion fracture cannot be determined by the limited information provided.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient had to be revised due to broken stem trunnion.A review of the provided medical records by a clinical consultant indicated: "the x-ray provided demonstrates a pressfit tha.The trunnion has fractured and the head has dissociated.While the event depicted in the x-ray would require revision surgery no information was provided that would confirm that this surgery did occur.The root cause of the trunnion fracture cannot be determined by the limited information provided." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and/or 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 through the submission of a revision usage sheet that the patient's hip was revised.A restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner were implanted.Update: trunnion on the existing stem had failed and broken off.
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Search Alerts/Recalls
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