Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
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Event Date 10/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of birth: (b)(6).Concomitant medical products: persona partial femur cemented catalog # 42558000502 lot # 63485124.Persona partial tibial cemented catalog # 42538000802 lot # 63458757.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-06669, 0001822565-2018-06684.
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Event Description
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It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient is experiencing pain, difficulty in regular activities and symptoms that required medical intervention.No revision procedure has been reported to date.
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Event Description
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From additional information, it was reported that the patient is experiencing limp and difficulty walking for extended time.
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Manufacturer Narrative
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Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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