(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00831 and 0001822565-2024-00832.D10 medical devices: nexgen articular surface size gh 12 mm height catalog#: 00596404212 lot#: 60493175 size 5 precoat cemented stemmed anterior/posterior wedged tibial component catalog#: 00598800500 lot#: 61473257.All poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535 lot#: 61437345.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|