BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - E1 VNGD AS TIB BRG 10X83

    MDR report key: 6578791 · Received May 19, 2017

    Report

    Report Number
    0001825034-2017-03381
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 10, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ REGENEREX PATELLA CATALOG 141357 LOT 344270; VANGUARD LEFT FEMUR 75MM CATALOG 183074 LOT 157830; BIOMET REGENEREX TIBIAL TRAY CATALOG 141276 LOT 572640; MODULAR SPLINED STEM 40MM CATALOG 141369 LOT 501970; 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1825034-2017-03380.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED BEARING SHOWED WEAR MARKS ON THE PRODUCT. THE BEARING HAS FLAKES OF METAL FROM THE REGENEREX BACKING ON THE ARTICULAR SURFACE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE ROOT CAUSE OF THE BEARING WEAR IS ATTRIBUTED TO THIRD BODY WEAR AS A RESULT OF THE PATELLA PEG FRACTURING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO WEAR AND COMPONENT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360260 VANGUARD COMPLETE KNEE SYSTEM - E1 VNGD AS TIB BRG 10X83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 802890

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R