(b)(4).Udi# (b)(4).Concomitant medical products: catalog number: ep-200150 lot number: 641560 brand name: act artic e1 hip brg, catalog number: 163663 lot number: 407210 brand name: 28mm dia cocr mod hd, catalog number: 11-300814 lot number: 130440 brand name:arcos 14x150mm spl catalog number: 11-301302 lot number: 615000 brand name:arcos con sz b std.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05088, 0001825034-2019-05089, 0001825034-2019-05090.0001825034-2019-05091 customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
|