Model Number N/A |
Device Problems
Unstable (1667); Noise, Audible (3273)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Type
Injury
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Event Description
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It was reported patient is experiencing pain, instability and popping in knee approximately 3 years post implantation.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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(b)(4).Medical product: e1 vngd as tib brg 13x71 catalog # ep-189063 lot # 315520; biomet cc i-beam tray 71mm catalog # 141223 lot # j6453610; series a pat std 34 3 peg catalog # 184766 lot # 641100.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: 0001825034-2022-01661; 0001825034-2022-01673; 0001825034-2022-01675.
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Manufacturer Narrative
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H6: component code: mechanical g4-femur.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.A definitive root cause cannot be determined.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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