MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ST PRC TIB PLT SIZE 6; PROSTHESIS, KNEE

Catalog Number	00598004702
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10- medical product unknown nexgen cr flex femur size g minus, unknown nexgen cr poly insert - 14mm, unknown nexgen patella button size 35mm.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.
Event or Problem Description
It was reported that a patient was revised due to tibial implant fracture and joint infection.Implants removed and cement spacer placed in situ to clear infection.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.Visual examination of the provided pictures identified the tibial plate is fractured along with the other explants are covered in foreign debris.As the implants were not returned, further evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap and lateral views of the right knee show changes of total knee arthroplasty with cemented components.There is radiolucency around the keel and posterior tray for the tibial component and posteromedial subsidence of the tibial component.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined for the tibial plate fracture and the infection for the unknown implants.After review of the sterilization certificate for the tibial plate, for the infection no problem was found with the tibia.This complaint is confirmed.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: ST PRC TIB PLT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22911476
• Report Number: 0002648920-2025-00226
• Device Sequence Number: 21094364
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)250806(10)62682565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/01/2025

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: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 00598004702
• Device Lot Number: 62682565
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 103 KG