Catalog Number UNK_REC |
Device Problems
Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348); Joint Dislocation (2374)
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Event Date 09/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number and lot code were not provided.The device was reported as an unknown 50 head v40 taper.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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The surgeon reported that he undertook revision surgery of an accolade stem, mitch bearing and a v40 taper head allegedly as a result of failed stem.During surgery black debris was noted around the implant and the surgeon reported that the trunnion looked as though it had worn away into a bullet shape.The representative was present in the case and it was not clear to him whether the trunnion had snapped altogether.The date of original surgery was 2008.The patient presented with a history of pain in the hip circa 9 months duration, prior to the revision.
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Manufacturer Narrative
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An event regarding wear involving an unknown head was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as medical records were not provided.-device history review: a review of the device history records could not be performed as device details were not provided.-complaint history review: a complaint history review could not be performed as device details were not provided conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
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Event Description
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The surgeon reported that he undertook revision surgery of an accolade stem, mitch bearing and a v40 taper head allegedly as a result of failed stem.During surgery black debris was noted around the implant and the surgeon reported that the trunnion looked as though it had worn away into a bullet shape.The representative was present in the case and it was not clear to him whether the trunnion had snapped altogether.The date of original surgery was 2008.The patient presented with a history of pain in the hip circa 9 months duration, prior to the revision.
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Search Alerts/Recalls
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