MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT MEDIAL SIZE EF 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 hair was found inside the sterile packaging of a right tibial augment.The surgeon implanted the device in the patient.All available information has been provided.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Follow up report.Updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6.Corrected: d1, h4.-no product was returned or pictures provided; visual evaluation could not be performed.-review of the device history records identified no deviations or anomalies during manufacturing.-reported event is not related to a combination of products; therefore, a compatibility review is not applicable.-review of complaint history found no additional related issues for the reported part and part lot combinations.-medical records were not provided for review.-a definitive root cause cannot be determined.-no actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint review to identify potential adverse trends.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 trend.

• Brand Name: TIBIAL AUGMENT CEMENTED HALF BLOCK RIGHT MEDIAL SIZE EF 5 MM THICKNESS
• 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: 22954190
• Report Number: 0001822565-2025-03237
• Device Sequence Number: 8453724
• Product Code: JWH
• UDI-Device Identifier: 00889024557192
• UDI-Public: (01)00889024557192(17)320223(10)65263069
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 42555805405
• Device Lot Number: 65263069
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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 Age: 54 YR
• Patient Sex: Male