Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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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)(6).Concomitant medical products - gender solutions flex system articular surface congruent # 00542402111 lot # 62432637; gender solutions tibial tray #630701220 lot # 62711317.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07869.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient body.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient is experiencing pain and the knee pops when she bends and walks.She is currently using a cane to walk and the knee is tender to touch.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per package insert, pain, dislocation and joint instability is one of the known adverse effects of the tka procedure.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.
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Event Description
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It was reported that the patient is experiencing pain, and the knee pops upon bending and pops out of place while walking.Patient uses a cane to walk and the knee is tender to touch.Attempts have been made and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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