Model Number N/A |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 09/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03420.
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Event Description
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It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported that patient underwent a hip revision approximately 30 years post implantation due to instability and normal wear and tear.Attempts have been made and additional information 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.The following sections were updated/corrected: updated: a1; a3; b2; b3; b5; d7; e1; e2; e3; g3; g4; h2; h6.Reportable event was confirmed by review of x-rays provided by a third party hcp noting right total hip arthroplasty with evidence of poly wear.Vertical positioning of the cup along with rounded licenses surrounding the cup were also found.Dhr was unable to be reviewed as the lot number of the device is unknown.Root cause is unable to 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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Search Alerts/Recalls
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