BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SERIES A STANDARD PATELLA

    MDR report key: 7656565 · Received July 2, 2018

    Report

    Report Number
    0001825034-2018-04399
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). (B)(6). MEDICAL PRODUCTS: VANGUARD XP FEMORAL CAT# 195920 LOT#: 743430 ; VANGUARD XP-XP TIBIAL TRAY INTERLOK CAT#: 195752 LOT#: 162900 ; VANGUARD XP TIBIAL LOCKING BAR CAT#: 195762 LOT#: 392470 ; VANGUARD XP-XP MEDIAL BEARING TIBIAL TRAY E1 ANTIOXIDANT INFUSED CAT#: 195878, LOT#: 835830 ; VANGUARD XP-XP LATERAL BEARING TIBIAL TRAY E1 ANTIOXIDANT INFUSED CAT#: 195808, LOT#: 865220. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04353, 0001825034 - 2018 - 04397, 0001825034 - 2018 - 04398, 0001825034 - 2018 - 04399, 0001825034 - 2018 - 04400, 0001825034 - 2018 - 04401. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS MANIPULATED UNDER ANESTHESIA TEN MONTHS AFTER PARTIAL KNEE ARTHROPLASTY DUE T UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498561 BIOMET SERIES A STANDARD PATELLA PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 526600

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R