MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POLY TIBIAL BUSHING; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 150480 - oss axle - 469410; 150477 - oss poly femoral bushings - 354010; 150493 - oss reinforced yoke - 933270; 150410 - oss tibial poly bearing 12mm - 581070; 150478 - oss poly lock pin - 794330; 150425 - oss mod tib baseplate 83mm - 978210; 150362 - oss cemented im stem 13mmx90mm - 178750.The 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00632, 0001825034-2021-00634, 0001825034-2021-00635, 0001825034-2021-00636, 0001825034-2021-00637, 0001825034-2021-00638, 0001825034-2021-00639.
Event or Problem Description
It was reported that the patient underwent a right knee revision.Subsequently, the patient was revised due to unknown reasons approximately three days later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, it was determined to be not reportable under this file, but reported under (b)(4).The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable under this file, but reported under (b)(4).The initial report should be voided.

• Brand Name: OSS POLY TIBIAL BUSHING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11415334
• Report Number: 0001825034-2021-00631
• Device Sequence Number: 17030273
• Product Code: JDI
• UDI-Device Identifier: 00880304002258
• UDI-Public: (01)00880304002258(17)250522(10)545940
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 150476
• Device Lot Number: 545940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/20/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention