(b)(4).Concomitant medical products: kne-persona-bearings-unk; p/n: unk, l/n: unk.Kne-persona-femorals-unk; p/n: unk, l/n: unk.Kne-persona-tibial trays-unk; p/n: unk, l/n: unk.Kne-persona-patellas-unk; p/n: unk, l/n: unk.Customer has not indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04551, 0001822565 - 2019 - 04552.
|
It was reported that the patient experienced bleeding, blood clots, and extreme pain.Subsequently, an x-ray 4 years post implantation showed evidence of possible loosening.Attempts have been made and no further information has been provided.
|