Catalog Number 00784801300 |
Device Problems
Naturally Worn (2988); Patient Device Interaction Problem (4001)
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Patient Problems
Failure of Implant (1924); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)
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Event Date 10/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01767 0001822565-2023-01769 d10: unknown kinectiv stem unknown versys head the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that a patient underwent a left hip revision approximately 13 years post implantations due to pain, metal relation pathology, elevated metal ion levels and periprosthetic fluid.During the procedure, black debris and necrotic tissue were observed and the bursal tissue was dissected.A periprosthetic fracture also occurred during attempted removal of initial components which required repair with cerclage wires and a small plate.The head and stem were ultimately exchanged with competitor product and there were no further complications noted.Attempts have been made and no further information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The complaint was confirmed based on the provided medical records.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 additional event information to report at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified there are scratches present and some damage to the taper edge of the taper and flat for the femoral head.The taper has black debris and damage inside of the taper.Visual inspection of the modular neck shows that there is damage to the taper and body with black debris on the taper.Visual inspection of the femoral stem shows damage to multiple spots with most of them in the area just outside of the taper entrance.There is additional damage to the stem porous coat extending into the non-porous coated area of the stem.The taper has damage and black debris inside of the taper.The head, neck, and stem were submitted for further analysis.Analysis determined a consensus score of 3 for all of the tapers on the neck and stem.The complaint is confirmed based on the provided medical records and returned devices.Dhr was reviewed and no discrepancies related to the reported event were found.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 additional event information to report at this time.
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Search Alerts/Recalls
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