MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX FXD MLD EF/3-4 12MM; PROSTHESIS, KNEE

Catalog Number	00596403212
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: stemmed tibial component precoat size 4: catalog#00598003702, lot#37221490.G2: foreign, event occurred in china.The device has been received by zimmer biomet for further evaluation.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the articular surface would not mate properly with the tibial tray.A secondary device was used to complete the procedure without further complication.There was no patient impact and no adverse events have been reported as a result of the malfunction.All available information has been provided.

• Brand Name: NEXGEN LPS-FLEX FXD MLD EF/3-4 12MM
• 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: 25255357
• Report Number: 0001822565-2026-01680
• Device Sequence Number: 10541936
• Product Code: JWH
• UDI-Device Identifier: 00889024634930
• UDI-Public: (01)00889024634930(17)280430(10)66005822
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 Catalogue Number: 00596403212
• Device Lot Number: 66005822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown