Catalog Number UNK_SHC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hip Fracture (2349)
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Event Date 01/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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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 by stryker sale rep that the patient did rthr 2001 under doctor and came to doctor with a fractured proximal posterior femur and requested a revision.Surgery scheduled on (b)(6) 2024 however, stryker sale rep couldn't find any information and details of the used implants.Only during intra-op while implants were explanted we could confirmed it was stryker product.
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Manufacturer Narrative
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An event regarding periprosthetic fracture involving an omnifit stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated damage consistent with explantation.There is nothing remarkable to note.Clinician review: no medical records were received for review with 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 has been no other similar event for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 by stryker sale rep that the patient did rthr 2001 under doctor and came to doctor with a fractured proximal posterior femur and requested a revision.Surgery scheduled on (b)(6) 2024 however stryker sale rep couldn't find any information and details of the used implants.Only during intra-op while implants were explanted we could confirmed it was stryker product.
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Search Alerts/Recalls
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