MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGD VE CR-L TIB BRG 79/83X10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00135.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during right total knee arthroplasty the locking clip was difficult to insert through the tibial insert and tibial tray.A second tibial insert and locking clip were used to complete the procedure.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00134 and 0001825034-2021-00770.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned product identified signs of slight wear and the non-functional side has deep gouges and surface scratches.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VGD VE CR-L TIB BRG 79/83X10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11154693
• Report Number: 0001822565-2021-00134
• Device Sequence Number: 11410729
• Product Code: JWH
• UDI-Device Identifier: 00889024565401
• UDI-Public: (01)00889024565401(17)241031(10)64506944
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: VE183560
• Device Lot Number: 64506944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/15/2021; 04/23/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/16/2021; 04/29/2021
• 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
• Patient Age: 50 YR
• Patient Weight: 109