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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling (2091); Tissue Damage (2104)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04159, and 0001822565-2020-04161.Implant date: unknown date in (b)(6) 2019.Medical devices: unknown femoral catalog#: ni lot#: ni, unknown tibial insert catalog#: ni lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 right knee pain, swelling, soft-tissue insufficiency, audible clicking, and leg length discrepancy approximately fourteen months post-implantation.No revision procedure has been reported.
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Search Alerts/Recalls
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