MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 79MM X 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during knee arthroplasty that upon opening up the articular surface implant, the device was identified to have a hair on it within the packaging.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
(b)(4).The complainant 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, d9, g3, g6, h2, h11.The following sections were corrected: d4, h4.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: a1, a2, a3, h4.A review of pictures provided and returned product identified a hair on the surface of the implant.However, the event could not be confirmed as the packaging was opened, the source of the debris is unknown and the condition of the device when it left zimmer biomet could not be determined.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 79MM X 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21055955
• Report Number: 0001822565-2025-00009
• Device Sequence Number: 12957430
• Product Code: JWH
• UDI-Device Identifier: 00889024564633
• UDI-Public: (01)00889024564633(17)291002(10)66943820
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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 Model Number: N/A
• Device Catalogue Number: VE189100
• Device Lot Number: 66943820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/14/2025; 04/15/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: Male