Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products: biomet ilok pri tib tray 71mm catalog # 141213 lot # 686560; vanguard cr ilok fem-rt 62.5 catalog # 183006 lot # j6555744; vngd cr lip tib brg 16x71/75mm catalog # 183546 lot # 324420.Series a pat std 34 3 peg catalog # 184766 lot # 613630; stryker cement catalog # unknown lot # unknown.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: 0001825034-2021-02306, 0001825034-2021-02314, 0001825034-2021-02315, 0001825034-2021-02316.
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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 and a crooked knee post surgery.Additionally, the patient was walking differently.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical review indicates that patient states right knee is experiencing issues, and left knee has no issues.States walks differently now knee goes inward and lower leg goes outward.X-ray review indicates that right knee arthroplasty components are anatomically aligned.There is no fracture or evidence of implant loosening.There is mild asymmetric right knee valgus when compared to the left knee.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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