Model Number N/A |
Device Problems
Fracture (1260); Unstable (1667)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Implant date : 2010.Concomitant medical products: unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.Report source: foreign country : netherlands.Customer has indicated that the product will not be 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 that the patient underwent an initial tka.The patient felt a snap while getting out of the car a while ago and his leg felt 'loose'.Subsequently, 12 years post-implantation, the patient was revised due to instability.During the revision procedure, it was discovered that the bearing had fractured and was replaced.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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