MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE FEM SIZE F LEFT; PROSTHESIS, KNEE

Catalog Number	00588001601
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: 12mm height size f articular surface with hinge post extension: catalog#00588006012, lot#65751077; size 4 precoat cemented tibial component: catalog#00588000400, lot#66226388; 12mm diameter 100mm length straight stem extension combined length 145mm: catalog#00598801012, lot#65813042; all poly petella standard cemented size 35 mm diameter 9.0 mm thickness: catalog#00597206535, lot#65366445; distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 5 mm augment with screw: catalog#00599003610, lot#64632331; distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 5 mm augment with screw: catalog#00599003610, lot#65539658; long 14mm diameter 155mm length straight stem extension combined length 200mm: catalog#00598801114, lot#64095181.G2: foreign: australia.H6: proposed component code: mechanical (g04) - femur.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total hinged knee arthroplasty.Approximately fourteen (14) months post-implantation, the patient underwent revision surgery due to disassociation of the femoral component.All components were replaced without reported complication.
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 and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.Visual evaluation of pictures provided identified residue on the device, however the extent of wear and damage could not be determined.Review of associated devices confirmed that the implants were not compatible.The device history records were reviewed and no discrepancies were identified.Per the package insert, to properly match the components, the femoral and tibial component size must both be reflected on the articular surface label.Mismatching may result in poor surface contact and may cause pain, greater wear, implant instability or otherwise reduce implant life.The root cause of the reported event is attributed to off-label usage.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN ROTATING HINGE KNEE FEM SIZE F 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 ; 5745260384
• MDR Report Key: 22344883
• Report Number: 0001822565-2025-02187
• Device Sequence Number: 11955047
• Product Code: JWH
• UDI-Device Identifier: 00889024199163
• UDI-Public: (01)00889024199163(17)280816(10)65789331
• 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: 2024
• 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): 10/14/2025

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 Catalogue Number: 00588001601
• Device Lot Number: 65789331
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG