MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD® KNEE SYSTEM; PROSTHESIS, KNEE

Catalog Number	183050
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.Suggested component code: mechanical (g04) ¿ femur.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a cementless femoral component was implanted during a total knee arthroplasty, and a discrepancy was later noted wherein the patient label identified the device as cemented.Prior to implantation, the surgical team confirmed with the surgeon that cementless fixation would be used.The circulating nurse opened the package, and the outer packaging (box lid) indicated a cementless/porous component.Subsequently, it was pointed out that the patient label indicated a cemented variant, while the implanted component and outer packaging corresponded to cementless.The patient had no known impact or consequence.Attempts have been made and no further information has been provided.

• Brand Name: VANGUARD® KNEE SYSTEM
• 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 ; 5745260384
• MDR Report Key: 24209251
• Report Number: 0001825034-2026-00249
• Device Sequence Number: 20207388
• Product Code: JWH
• UDI-Device Identifier: 00880304270626
• UDI-Public: (01)00880304270626(17)3000218(10)506340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 183050
• Device Lot Number: 506340
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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
• Patient Sex: Unknown