MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during knee arthroplasty that the surgeon attempted to seat an articular surface in the tibial tray; however, the articular surface screw was unable to be screwed in.A second articular surface implant was opened; however, the same issue occurred.Finally, a third articular surface was opened and yet the same issue occurred again.It is unknown how the procedure was completed; however, no adverse events have been reported to date.Attempts have been made; however, no additional information was reported.
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: event occurred in france.The complainant has not yet indicated whether the product will 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.
Event or Problem Description
It was reported during knee arthroplasty that the surgeon attempted to seat an articular surface in the tibial tray; however, the articular surface screw was unable to be screwed in.A second articular surface implant was opened; however, the same issue occurred.Finally, a third articular surface was opened and yet the same issue occurred again.The surgeon decided to use the third articular surface, however, it was unable to be fixed.No adverse events have occurred since the procedure and there is no plan to revise at this time.Attempts have been made; however, no additional information was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review; however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.The surgery was completed without the articular surface screw, which is considered off-label use.The surgical technique states that a secondary locking screw is required for the 17mm and thicker bearing components when used with lps-flex components.Further details on proper assembly are provided within the technique.The technique further states to not use the product for other-than-labeled indications (off-label use).However, a definitive root cause could not be determined for the articular surface not seating with the tibial plate.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20533868
• Report Number: 0001822565-2024-03394
• Device Sequence Number: 15123715
• Product Code: JWH
• UDI-Device Identifier: 00889024211971
• UDI-Public: (01)00889024211971(17)260630(10)64048596
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596404017
• Device Lot Number: 64048596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 04/03/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/14/2024; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 81 KG