MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL BEARING CRUCIATE RETAINING (CR) 71/75 MM WIDTH 10MM THICKNESS; PROSTHESIS, KNEE

Catalog Number	VE183440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, one (1) year and seven (7) months post-implantation, the patient began to experience instability.A revision surgery was performed and the articular surface was exchanged without reported complication.It was reported that no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: vanguard cr ilok fem-lt 65: catalog#183028, lot#j7323878; biomet cc cruciate tray 71mm: catalog#141233, lot#j7362703; series a pat thin 37x8.6 3 peg: catalog#184788, lot#277350; refobacin bc r 1x40 us: catalog#110034355, lot#ax13ab0302; refobacin bc r 1x40 us: catalog#110034355, lot#y38baj2102.The product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Radiographs were provided and reviewed by a health care professional and it was determined further review would not enhance the investigation.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 TIBIAL BEARING CRUCIATE RETAINING (CR) 71/75 MM WIDTH 10MM 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: 20136266
• Report Number: 0001822565-2024-02814
• Device Sequence Number: 14259654
• Product Code: JWH
• UDI-Device Identifier: 00889024564985
• UDI-Public: (01)00889024564985(17)251015(10)64899328
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 12/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2025
• Device Catalogue Number: VE183440
• Device Lot Number: 64899328
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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
• Patient Weight: 108 KG