MAUDE Adverse Event Report: ZIMMER BIOMET INC. VANGARD CR TIB BRG 10X63/67; PROSTHESIS, KNEE

Catalog Number	183420
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525); Joint Laxity (4526); Implant Pain (4561); Crepitus (4893)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown femur - unknown.G2: foreign - event occurred in australia.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
It was reported a patient had an initial right total knee arthroplasty.Subsequently, the patient developed instability, patellofemoral pain, subluxation from extended to flexed position, patellofemoral subluxation, and crepitus.Approximately, 10.6 years post-op underwent a revision where the articular surface was worn and the patella was resurfaced.The articular surface was revised, and all other implants were retained.Attempts have been made and all available information has been provided.

• Brand Name: VANGARD CR TIB BRG 10X63/67
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET INC.; 56 e. bell dr.; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell dr.; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24940841
• Report Number: 0001825034-2026-01002
• Device Sequence Number: 5651046
• Product Code: JWH
• UDI-Device Identifier: 00880304271050
• UDI-Public: (01)00880304271050(17)200423(10)760300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 07/09/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: 183420
• Device Lot Number: 760300
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 06/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 07/08/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female