Model Number N/A |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Information (3190)
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Event Date 05/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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: 0001822565-2017-03984.
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Event Description
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It was reported a patient underwent a right knee revision approximately three years post-implantation due to tibial component loosening.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been 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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Search Alerts/Recalls
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