Catalog Number 010000934 |
Device Problems
Detachment of Device or Device Component (2907); Noise, Audible (3273)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 08/10/2023 |
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: 0001825034-2023-02065.D10: unknown shell.G2: taiwan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported a patient underwent a hip revision approximately one month post implantation due a noise and the cup and liner separating.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.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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.Upon visual inspection of the returned liner, the locking feature of the device has been damaged and deformed.There are scratches going perpendicular to the locking feature.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: eccentric position of the prosthetic femoral head within the acetabular cup reflecting liner wear or displacement as noted.The event is confirmed based on a review of the provided x-rays.A definitive root cause cannot be determined.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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