ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
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Event Date 03/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps) catalog # 42500006202 lot # 62034136.Persona natural tibia cemented catalog # 42532006702 lot # 63331185.Persona all poly patella catalog # 42540000035 lot # 63463168.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.Multiple mdr reports were filled for this event: 3007963827-2020-00141, 0001822565-2020-01765, 0001822565-2020-01767.Device evaluated by manufacturer? remains implanted.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing moderate pain, increased instability, and a mild effusion.No intervention or revision has been reported to date.Attempt for further information has been made, but no further information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.Medical records review indicates that at 1-year patient had moderate instability, pain and x-ray findings of 3.6mm radiolucency of the posterior condyle.At 2-year follow-up severe instability, rom 110 degree, moderate pain, mild effusion and x-rays findings of 3.0mm tibial radiolucency.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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