(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical : item # 00450004500, tm ankle tibial base size 5, lot 00077003944; item # 00450005500, prolong tibial insert sz 5 +0, lot # 00062560621; item # 00493600703, locking one-third tubular plate 7 holes 94 mm length, lot # 00060864063.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05154, 0001822565 - 2018 - 05156, 0001822565 - 2018 - 05157.
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It was reported that approximately three (3) years post implantation, the patient noted clicking/locking, with mild swelling and stiffness.X-ray has also indicated subsidence of the talar component.No medical intervention at this time.Attempts have been made and no further information has been provided.
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