(b)(4).D10 - concomitant devices - unknown persona femoral trial, catalog #: ni, lot #: ni.Photographs provided identified that the trial and articular surface exhibited evidence of explantation (surgical suite background and surgical debris).The device history records could not be reviewed as the lot number associated with the reported event is unknown.The reported devices were determined to not be compatible.The root cause is attributed to an off-label issue.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-02829.
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It was reported that during a first stage revision for infection, the surgeon implanted a femoral trial and an articular surface as a spacer temporarily.The femoral trial was then removed during the second stage revision.Attempts have been made; however, no additional information is available.
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