MAUDE Adverse Event Report: Zimmer Biomet, Inc. NG ROT.HINGE KNEE TIB PLT SZ4; Prosthesis, Knee

Catalog Number	00588000400
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Aseptic loosening (4883)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately seven years and seven months post implantation due to tibial loosening and a fractured tibial bone.There is no additional information available.
Additional Manufacturer Narrative
(b)(4) d10- medical product 12mm diameter 100mm length straight stem extension combined length 145mm item# 00598801012 lot# 63965174.Tibial block and screws precoat size 4 5 mm thickness item# 00598800426 lot# 64059448.Tibial block and screws precoat size 4 5 mm thickness item# 00598800426 lot# 64027698.Articular surface with segmental hinge post size c 20 mm height item# 00585003020 lot# 63179186.Polyethylene insert size c item# 00585001395 lot# 63503582.G2- australia h3- customer has indicated that the product will not 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: NG ROT.HINGE KNEE TIB PLT SZ4
• 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: 50036898
• Report Number: 0001822565-2026-02681
• Device Sequence Number: 9788547
• Product Code: JWH
• UDI-Device Identifier: 00889024199026
• UDI-Public: (01)00889024199026(17)221231(10)63814357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/27/2026

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: 12/31/2022
• Device Catalogue Number: 00588000400
• Device Lot Number: 63814357
• 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: 07/08/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Unknown