MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LPS-FLEX FIXED XL E/12 10MM; PROSTHESIS, KNEE

Catalog Number	00596202410
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- india.H3- customer has indicated that 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 that during a total knee replacement procedure on an unknown date, the circulating operating room staff opened a sealed pack of an articular surface and handed it to the surgeon for implantation.The surgeon noted that the locking mechanism was not functioning and, upon closer inspection, the locking mechanism appeared damaged.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d9, g1, g3, g6, h1, h2, h3, h6, and h11.Visual examination of the returned product identified signs of use and attempted implantation in the form of scratches, dings, and gouges near the extraction slot.Evaluation of the locking feature (dovetail) found the feature to be both flared and compressed.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the surgical technique.The root cause is attributed to use error.This complaint is confirmed.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: LPS-FLEX FIXED XL E/12 10MM
• 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: 23696694
• Report Number: 0001822565-2025-04366
• Device Sequence Number: 21404731
• Product Code: JWH
• UDI-Device Identifier: 00889024665811
• UDI-Public: (01)00889024665811(17)291126(10)67066548
• 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): 05/06/2026

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: 00596202410
• Device Lot Number: 67066548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/09/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Female