MAUDE Adverse Event Report: Zimmer Biomet, Inc. Vanguard SERIES A PAT W/WR THN 25 1 PEG; Prosthesis, Knee

Catalog Number	184720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right total knee arthroplasty.Subsequently, the patient underwent an additional procedure approximately 1 year post-op to realign and adjust the kneecap due to ongoing swelling, nerve pain, inflammation, and scar tissue with restricted range of motion.No devices were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 183108 - van ps open intl fem-rt 65 - j7701418; ve183620 - tibial bearing posterior stabilized (ps) 63/67 mm width 10 mm thickness - 66786333 unknown - unknown locking bar - unknown; 110034355 - refobacin bc r 1x40 us - aw51dc0103.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.

• Brand Name: Vanguard SERIES A PAT W/WR THN 25 1 PEG
• Common Device Name: Prosthesis, Knee
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50278278
• Report Number: 0001825034-2026-02392
• Device Sequence Number: 10437448
• Product Code: JWH
• UDI-Device Identifier: 00887868344015
• UDI-Public: (01)00887868344015(17)280201(10)65783341
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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 Catalogue Number: 184720
• Device Lot Number: 65783341
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female