MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 71/75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D2 - concomitant devices - unknown vanguard femoral component catalog #: ni lot #: ni, unknown biomet tibial tray catalog #: ni lot #: ni.G2 - report source - foreign: event occurred in australia.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.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address unknown reasons post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, b5, d1, d4, d6a, d10, g3, g6, h2, h4, h6, h11.D10 - concomitant devices - vanguard cruciate retaining femoral component left 72.5mm catalog #: 183033 lot #: j3764239, biomet series a 3-peg thin patella 37mm x 8.6mm catalog #: 184788 lot #: 511180, vanguard polished finned tibial tray 75mm catalog #: 141254 lot #: 2017030797, palacos r + g 1x40 catalog #: 66022663 lot #: 80854436, palacos r + g 1x40 catalog #: 66022663 lot #: 80854436.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address instability approximately six (6) years post-operatively.Initial operative notes noted no intraoperative complications.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Medical records were provided, however, no abnormalities were identified and the complaint was not confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 71/75MM
• 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: 20363411
• Report Number: 0001825034-2024-02330
• Device Sequence Number: 3795760
• Product Code: JWH
• UDI-Device Identifier: 00880304271135
• UDI-Public: (01)00880304271135(17)220914(10)082450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 01/23/2025

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: 09/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 183440
• Device Lot Number: 082450
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 01/22/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/13/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2017
• 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: Required Intervention; Hospitalization; Required Intervention; Hospitalization
• Patient Sex: Male