MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIB PLATE SZ3 PMMA NON MODULAR; PROSTHESIS, KNEE

Catalog Number	00588000302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Periprosthetic fracture (4902)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00588003012, 12mm height size c articular surface with hinge post extension, lot 65672136.00598801215, 15mm diameter 30mm length straight stem extension combined length 75mm 15mm diameter 30mm length straight stem extension combined length 75mm, lot 67279702 00588001302, right size c cemented option femoral component, lot 66671292.G2: event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had undergone a primary right total knee arthroplasty.Subsequently, the patient underwent a revision due to fall and dislocation approximately 2 years and 6 months.Now, approximately 3 months post revision, the patient has undergone a second revision due to periprosthetic fracture of the tibia.Attempts have been made and no additional information is available.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event could not be confirmed due to lack of product.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no discrete periprosthetic fracture is identified.The device history record was reviewed and no discrepancies relevant to the reported event were found.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: TIB PLATE SZ3 PMMA NON MODULAR
• 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: 23568121
• Report Number: 0001822565-2025-04134
• Device Sequence Number: 15933876
• Product Code: JWH
• UDI-Device Identifier: 00889024199002
• UDI-Public: (01)00889024199002(17)300415(10)66949268
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00588000302
• Device Lot Number: 66949268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Female