MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 14MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Catalog Number	00588006014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Joint effusion (4849)
Date of Event	01/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in italy.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a knee revision approximately 18 months post implantation due to pain, instability, hypertensive knee, edematous, and hemarthrosis.During the revision the hinge was reported to be disassembled, and the femoral and tibial components were noted to be well fixed.The hinge replacement was completed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d6a; g3; g6; h1; h2; h3; h6; h11.Visual examination of the provided pictures identified the explanted bearing, hinge and post, the femoral part is not shown in the picture.The devices are disassembled and partially covered by patient's blood.No further damages can be seen from the picture provided; no further assessment can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient presented with an unstable, hyperextended knee, hemarthrosis, and pain.During the procedure, the previous incision was utilized, and the hinge was disassembled.Both the femoral and tibial components were found to be well fixed.The surgical team proceeded with the use of special instrumentation to core the medial epicondyle and perform a hinge replacement.Radiographs: implant disassembly of the left knee arthroplasty.A definitive root cause cannot be determined.This complaint can be confirmed based on the medical records, radiographs and picture of the explanted devices.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN 14MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION
• 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: 21270017
• Report Number: 0001822565-2025-00206
• Device Sequence Number: 3916094
• Product Code: JWH
• UDI-Device Identifier: 00889024199439
• UDI-Public: (01)00889024199439(17)251130(10)64834877
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 05/29/2025

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: Lay User/Patient
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 00588006014
• Device Lot Number: 64834877
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: 54 YR
• Patient Sex: Unknown
• Patient Weight: 105 KG