(b)(4).Concomitant medical products: item#: unknown; kne-vanguard-femorals-unk; lot#: unknown.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00426.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the revision surgery.On (b)(6) 2016, the patient started experiencing periprosthetic soft tissue impingement.On (b)(6) 2016, the patient experienced pain.In a month, the patient complained about soft tissue snapping, and the current surgeon referred to another surgery as he believes the revision surgery would make it worst.On (b)(6)2018, strong chance of posterior knee instability, possibly pcl deficiency causing ap pain, options to do nothing or possibly revise to the posterior stabilizing knee.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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