It was reported that the patient under went a left knee replacement surgery.Subsequently, it was found during the procedure that the sterile packaging of the femoral component was damaged.Due to the sterility of the device being compromised the surgeon decided to use size 57,5mm femoral component instead of the planned 55mm.
|
It was reported that the patient under went a left knee replacement surgery.Subsequently, it was found during the procedure that the sterile packaging of the femoral component was damaged.Due to the sterility of the device being compromised the surgeon decided to use size 57,5mm femoral component instead of the planned 55mm.
|
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Visual inspection confirmed the reported event.The product left manufacturing site conforming to specifications according to the mhr review.The root cause of the reported event is likely to be transit damage.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.
|