Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 08/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 01627; 0001825034 - 2018 - 01629.Medical devices: 154602 oxford uni femoral lg lot j3341076; 159555 oxf anat brg lt lg size 4 pma lot 3452312.Report source: foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.Device remains implanted.
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Event Description
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Clinical study (b)(6)- it was reported that patient enrolled in a clinical study underwent a left knee procedure on (b)(6) 2015.Subsquently the patient reported episodes of severe to moderate pain with difficulty performing daily activities or using stairs, walking with a limp, and being "housebound" during six months post op visit.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.Please void this submission.
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Search Alerts/Recalls
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