BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM

    MDR report key: 6989976 · Received October 31, 2017

    Report

    Report Number
    0001825034-2017-09728
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    July 12, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) K042757. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: UNKNOWN KNEE BEARING CAT#: UNK, LOT#: UNK, BIOMET OFFSET ADAPTER CAT#: 185210, LOT#: 881840, VANGUARD SSK DISTAL FEMORAL AUGMENT CAT#: 185388, LOT#: 008930, VANGUARD SSK POSTERIOR AUGMENT CAT#: 185428, LOT#: 818310, VANGUARD SSK POSTERIOR AUGMENT CAT#: 185348, LOT#: 029320, VANGUARD SSK FEMORAL CAT#: 185268, LOT#: 3400701, BIOMET SMOOTH KNEE STEM CAT#: 145024, LOT#: 303320, VANGUARD TIBIAL TRAY CAT#: 161432, LOT#: 3431122, BIOMET SMOOTH KNEE STEM CAT#: 145000, LOT#: 226130. FOREIGN- (B)(4). THE IMPLANTING HOSPITAL IS IN (B)(6), BUT THE EVENT IS REPORTED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION APPROXIMATELY 2 YEARS POST OP DUE TO POLYETHYLENE EXCHANGE DUE TO INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOLLOWING POLYETHYLENE EXCHANGE DUE TO INSTABILITY, TWO YEARS FOLLOWING THE RIGHT KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769141 VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM PROSTHESIS, KNEE JDG ZIMMER BIOMET, INC. N/A 3407781

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R