Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
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Event Date 06/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: vanguard cr ilok fem-rt 70 catalog # 183012 lot # j6452368.Biomet cc i-beam tray 83mm catalog # 141226 lot # j6475328.The complainant 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: 0001825034-2020-00735, 0001825034-2020-00739.Remains implanted.
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Event Description
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It was reported that the patient had a total knee arthroplasty.Subsequently, the patient experienced knee stiffness, pain swelling, and arthrofibrosis that resulted in a manipulation under anesthesia.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.D4: (b)(4).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 patient had issues with range of motion, and was experiencing stiffness and arthrofibrosis and underwent manipulation under anaesthesia on (b)(6) 2019.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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