MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY; KNEE INSTRUMENT

Catalog Number	141233
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the surgeon found stain on the sterile device of tibial component surface.Another device was used to complete the surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been corrected: b5; d4; h4.The following sections have been updated/corrected: b4; d5; g3; h2; h3; h6; h11.Visual inspection of the provided photograph shows stains on it however it cannot be confirmed how and when the stains occurred.The device was not returned and has been implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was confirmed by review of provided photograph.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 the surgeon found stain on the sterile device of tibial component surface.The device was used to complete the surgery at the surgeon's discretion.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: BIOMET CC CRUCIATE TRAY
• Common Device Name: KNEE INSTRUMENT
• 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: 21559596
• Report Number: 0001825034-2025-00623
• Device Sequence Number: 9602014
• Product Code: JWH
• UDI-Device Identifier: 00887868558672
• UDI-Public: (01)00887868558672(17)340119(10)J7704104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171054
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 141233
• Device Lot Number: J7704104
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: Unknown