Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Code Available (3191)
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Event Date 12/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Concomitant medical products: item #163660 femoral head lot #072390.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00509, 00510.
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Event Description
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It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 4 months later due to disassociation.The liner separated from the femoral head.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection found the head to be free of any major notable damage.A small amount of surface scratching and scuffing was observed on the outer radius.Dimensional analysis was performed and found to be within the print specifications.The shell, ring and liner remain assembled upon receipt.The locking ring can be seen in all 6 of the cutouts of the liner indicating that the liner is appropriately seated.Visual inspection found gouging on the rim of the liner.No notable damage was observed on the liner¿s inner radius.A small amount of wear was observed on the outer radius of the shell in the form of scuffing and scratches.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation was sent to the complainant.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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It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 4 months later due to disassociation.The liner separated from the femoral head.Attempts have been made, and no further information has been provided.
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Search Alerts/Recalls
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