MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX; PROSTHESIS, KNEE

Catalog Number	00596202212
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon attempted to fix the poly to the tibial plate multiple times, however, it kept popping out repeatedly as the locking mechanism was not functioning properly.There was no surgical delay.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) - stemmed tibial component precoat size 2 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - j7813383 g2: foreign country: india.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6 the event is confirmed.Visual examination of the returned product identified found the distal surface to exhibit damage in the form of surface scratches and gouging with the locking feature (dovetail) found to be flared out.Dimensional analysis of the product determined that the product was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 USE WITH LPS/LPS-FLEX
• 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: 21325583
• Report Number: 0001822565-2025-00287
• Device Sequence Number: 20865235
• Product Code: JWH
• UDI-Device Identifier: 00889024665767
• UDI-Public: (01)00889024665767(17)280923(10)66212557
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/22/2025

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 Catalogue Number: 00596202212
• Device Lot Number: 66212557
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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.
• Patient Sex: Unknown