STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6020-0537 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)
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Event Date 10/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2006 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood updated: head disassociation.
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Manufacturer Narrative
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Reported event: an event regarding disassociation and abnormal ion level involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported accolade stem was mated with a lfit v40 cocr head.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The exact cause of abnormal ion level 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 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 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 filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2006 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Updated: head disassociation.
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