MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT FEMORAL; PROSTHESIS, KNEE

Catalog Number	00588001402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee surgery with competitor products.After approximately 12 years, they had a revision due to unknown reason with placement of zb product.No operative records provided.Then, about a year later the patient had a right knee exploration of extensor tendon.No further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.D10: therapy date: unknown date on (b)(6) 2023.66022663, palacos r + g (1x40), 98971042.20800000020, iassist pin & screw pack sterile, 65107668.Unknown, tibial component, unknown.Unknown, articular surface, unknown.H6: proposed component code: mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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 information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported event could not be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided and reviewed state that the patient underwent an initial right total knee arthroplasty on an unknown date in 2010.No operative report for this primary procedure was available for review.On 07-apr-2022, the patient had a right knee revision procedure for an unspecified reason, during which the first known zimmer biomet components, a nexgen rh femur (lot 64695390) and palacos cement (lot 98971042), were implanted; however, no operative findings or detailed surgical documentation were provided.Subsequently, on an unknown date in february 2023, the patient underwent a right knee exploration of the extensor tendon for an unidentified indication, and again, no operative note or findings were available.A definitive root cause cannot be determined.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.

• Brand Name: ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT FEMORAL
• 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: 23815614
• Report Number: 0001822565-2025-04519
• Device Sequence Number: 9963647
• Product Code: JWH
• UDI-Device Identifier: 00889024199132
• UDI-Public: (01)00889024199132(17)250915(10)64695390
• 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: 2022
• 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): 01/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/15/2025
• Device Catalogue Number: 00588001402
• Device Lot Number: 64695390
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female