MAUDE Adverse Event Report: Zimmer Biomet, Inc. ART SURFACE 20MM FEM SZ D; Prosthesis, Knee

Catalog Number	00588004020
Medical Device Problem Codes	Fracture (1260); Damaged Thread (4075)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately three years and nine months post implantation due to pain caused by implant fracture.The patient experienced pain and x-rays showed metallic pieces inside.At explant, the femoral condyle hinge was found fractured in half.The rotational bolt had engaged the proximal threaded portion that articulates in the hinge.There is no additional information available.
Additional Manufacturer Narrative
(b)(4) d10-medical product fem size d left item# 00588001401 , lot# 65081206.G2- spain 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.

• Brand Name: ART SURFACE 20MM FEM SZ D
• 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 ; +1(574)526-0384
• MDR Report Key: 50915012
• Report Number: 0001822565-2026-03254
• Device Sequence Number: 5999045
• Product Code: JWH
• UDI-Device Identifier: 00889024199330
• UDI-Public: (01)00889024199330(17)241130(10)64495367
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 09/28/2026

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: 11/30/2024
• Device Catalogue Number: 00588004020
• Device Lot Number: 64495367
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 165 LB