MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL BEARING (AS) 71 MM WIDTH 11 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately four months post-implantation due to the locking bar backing out.The tibial insert and locking bar were removed and replaced.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: biomet cc i-beam tray 71mm, catalog #: 141223, lot #: j7671806.Vanguard cr ilok fem-rt 70, catalog #: 183012, lot #: j7621010.Series a pat thn 34 3 peg, catalog #: 184786, lot #: 66406678.Customer 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 information.Updated: b4, g3, g6, h2, h3, h6, and h11.Reported event was confirmed by review of medical records.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: marked medial displacement of the tibial implant locking bar.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined.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 TIBIAL BEARING (AS) 71 MM WIDTH 11 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: 19741263
• Report Number: 0001822565-2024-02349
• Device Sequence Number: 7655386
• Product Code: JWH
• UDI-Device Identifier: 00889024564503
• UDI-Public: (01)00889024564503(17)270516(10)65503752
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VE189061
• Device Lot Number: 65503752
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female