BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM

    MDR report key: 21477043 · Received February 27, 2025

    Report

    Report Number
    3002806535-2025-00096
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    January 4, 2025
    Report Date
    February 27, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024230347. D-10: 183420, VNGD CR TIB BRG 10X63/67, LOT 243080. 141361, BM FNN TB TRY POLIS POR+HA63MM R+HA 63MM, LOT 2008041091. G-2: AUSTRALIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K230321. NO PRODUCT WAS RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. THE IMAGES SHOW THE PRODUCT COVERED IN BLOOD, WITH SOME DENTS VISIBLE ON BOTH THE ANCHORING AND ARTICULATING SURFACES. DESPITE THESE OBSERVATIONS, THE OVERALL CONDITION OF THE PRODUCT APPEARS UNREMARKABLE. ON THE ANCHORING SURFACE, SOME MATERIAL IS PRESENT, BUT DUE TO THE IMAGE QUALITY, IT IS UNCLEAR WHETHER IT IS BONE OR CEMENT. THE POOR RESOLUTION OF THE PICTURES LIMITS THE ABILITY TO PERFORM A MORE DETAILED ASSESSMENT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT KNEE SHOW A RIGHT TOTAL KNEE ARTHROPLASTY WITH NARROWING OF THE MEDIAL AND LATERAL COMPARTMENTS, INDICATING POLYETHYLENE WEAR. THERE IS SIGNIFICANT RADIOLUCENCY BETWEEN THE HARDWARE AND THE BONE IN THE ANTERIOR FEMORAL COMPARTMENT, WHICH IS CONSISTENT WITH LOOSENING, AND MODERATE JOINT EFFUSION IS ALSO OBSERVED. TAKEN TOGETHER, THESE FINDINGS POINT TO POSSIBLE INFECTION. MILD OSTEOPENIA IS ALSO PRESENT. MEDICAL RECORDS WERE NOT PROVIDED, THEREFORE THE EVENT OF INFECTION COULD NOT BE CONFIRMED. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WAS PERFORMED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. DESPITE THE INITIAL ALLEGATION IS FOR INFECTION, PROVIDED RADIOGRAPHS POINT TO A POSSIBLE LOOSENING OF IMPLANT. NEVERTHELESS, BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THE EVENT OF LOOSENING CANNOT BE ESTABLISHED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED THIRTEEN YEARS POST IMPLANTATION DUE TO INFECTION. PHOTOS RECEIVED OF THE EXPLANTED DEVICES SHOW WEAR OF THE BEARING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027469 VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM KNEE PROSTHESIS JWH BIOMET UK LTD. 1462407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.