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Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Patient¿s year of birth is 1952.Medical products: biomet tibial plate catalog # 114126 lot # 085820, vanguard (tm) cr femoral catalog # 183054 lot # 709350, biomet series a standard patella catalog # 184768 lot # 996200, biomet modular finned stem catalog # 141314 lot # 951910, cobalt hv with gentamicin bone cement catalog # 402283 lot # 674550.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: 0001825034-2019-04887, 0001825034-2019-04904, 0001825034-2019-04905.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 pain, noise, stiffness, decrease in adls and overall decrease in satisfaction at three year follow-up visit.
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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 three years patient was experiencing pain and often fells grinding and hears clicking.Very stiff and difficulty with functional abilities.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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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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