It was reported that a few days following an initial arthroscopy procedure, the patient experienced implant dissociation.The patient underwent additional surgery approximately one (1) week following the original procedure, and the surgeon discovered that the central screw wasn't fully tightened, causing the looseness.The screw was adjusted, and other concomitant devices were retained during the revision, with no other patient harm reported.Attempts have been made, and no further information has been provided.
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(b)(4).D10: concomitant medical products, part number (lot number): 115396 (unknown), 110027734 (66500759).Associated product information: 113633 (64964350), 180554 (unknown), 180554 (unknown), 180555 (unknown), 180555 (unknown), 180556 (unknown), 405800 (66394301), 110010066 (66500764), 110030777 (66072611), 110031400 (66394125), 110031429 (65434183).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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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