MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SERIES A PAT STD 37 3 PEG; PROSTHESIS, KNEE

Catalog Number	184768
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.Customer has indicated that the product is in process of being 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 that the red substance was on the patella implant surface when opening the packaging.As a result, the surgery was successfully completed with another patella.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3a; b1; b5; d1; d2a; d2b; d4; d9; e1; g1; g3; h1; h3; h6.The following sections were updated: h3; h6; h11.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified small scratches near the edge along with a red substance on a groove near surface scratches.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Additional further testing of the red substance could not be performed due to an insufficient amount of the red substance present and it could not be removed from the implant surface.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.
Event or Problem Description
It was reported that a red substance was observed on the patella implant surface upon opening the packaging on an unknown date.When the sterile package was opened in preparation for implantation during a knee arthroplasty, the red substance was noted on the patella implant surface.The affected device was not used.The procedure continued and was successfully completed with another patella.No environmental factors were reported.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.

• Brand Name: VANGUARD SERIES A PAT STD 37 3 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 ; 5745260384
• MDR Report Key: 22479857
• Report Number: 0001825034-2025-02050
• Device Sequence Number: 15589489
• Product Code: JWH
• UDI-Device Identifier: 00887868344107
• UDI-Public: (01)00887868344107(17)270309(10)696370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 184768
• Device Lot Number: 696370
• Was Device Available for Evaluation?: Yes
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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