MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNI FEMORAL COMPONENT HIGH FLEX PRECOAT FOR CEMENTED USE ONLY; PROSTHESIS, KNEE

Catalog Number	00584201502
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an initial surgery, subsequently it was reported that a femoral component broke, so the patient had a revision surgery.
Additional Manufacturer Narrative
(b)(4).D10: catalog#: 00584202310, articular surface size 3 10 mm height femoral size a, b, c, d, e, f, g, lot#: 63504308.Catalog#: 00584200302, tibial component precoat right medial/left lateral size 3, lot#: 63887089.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
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.The following sections were updated: b4; b5; d2; d6; g1; g3; g6; h1; h2; corrected: h6 clinical and device code.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual examination of the returned implant found signs of use and implantation in the form of scratches and gouges, along with bone cement still bonded to the implant¿s surface.The implant was found to be fractured.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The devices were submitted for further analysis.Analysis of the femoral implant fracture found the distal and proximal fracture to show fatigue artifacts such as ratchet marks and beach marks, which are consistent with fatigue mode of fracture.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.

• Brand Name: ZIMMER UNI FEMORAL COMPONENT HIGH FLEX PRECOAT FOR CEMENTED USE ONLY
• 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: 21948752
• Report Number: 0001822565-2025-01224
• Device Sequence Number: 12970843
• Product Code: JWH
• UDI-Device Identifier: 00889024193796
• UDI-Public: (01)00889024193796(17)260731(10)63424694
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 00584201502
• Device Lot Number: 63424694
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 10/15/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/04/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Unknown