MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR TIB BRG 12X63/67; PROSTHESIS, KNEE

Catalog Number	183422
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: vanguard cr ilok fem-rt 60: catalog#183004, lot#459270; polished finned tib tray 67mm: catalog#141252, lot#2019041655; series a pat thn 34 3 peg: catalog#184786, lot#616950; palacos r + g (1x40): catalog#66022663, lot#91764792; palacos r + g (1x40): catalog#66022663, lot#91174794.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately five (5) years and five (5) months post-implantation, the patient underwent revision surgery due to instability in the knee.The articular surface and tibial locking bar were exchanged without reported complication.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.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 unable to be confirmed.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
No further event information at time of this report.

• Brand Name: VANGUARD CR TIB BRG 12X63/67
• 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: 20875066
• Report Number: 0001825034-2024-02884
• Device Sequence Number: 12933623
• Product Code: JWH
• UDI-Device Identifier: 00880304271067
• UDI-Public: (01)00880304271067(17)230430(10)182710
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 183422
• Device Lot Number: 182710
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female