Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); No Information (3190)
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Event Date 05/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog number:00801803603, lot number: 62514865, brand name: femoral head.Catalog number:00620005820, lot number:62542641, brand name: trilogy shell.Catalog number: 00630505836, lot number:62598727, brand name: acetabular liner.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00309.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
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Event Description
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It was reported that the patient was revised due to unknown reasons approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Event Description
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It was further reported that the patient was revised due to metallosis approximately 4 years post implantation.The surgeon noted during the revision procedure that there was necrosis of the muscle, 95 percent of the greater trochanter was gone and the greater trochanter was dead.Further, there was trunnionosis within the head and on the trunnion.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Corrected: d6b - patient retained this device as the femoral was well-fixed.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Additional medical records were provided and reviewed.The stem was retained upon completion of this revision, and the part number of the versys head that was implanted was provided.No further information was provided for this revision.Device history record (dhr) was reviewed and no discrepancies were found.The root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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