MAUDE Adverse Event Report: Zimmer Biomet, Inc. FEM SIZE D LEFT; Prosthesis, Knee

Catalog Number	00588001401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury

• Brand Name: FEM SIZE D LEFT
• 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: 50914990
• Report Number: 0001822565-2026-03253
• Device Sequence Number: 14891224
• Product Code: JWH
• UDI-Device Identifier: 00889024199125
• UDI-Public: (01)00889024199125(17)260823(10)65081206
• 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: 08/23/2026
• Device Catalogue Number: 00588001401
• Device Lot Number: 65081206
• 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: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 165 LB