BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR FEMORAL

    MDR report key: 7764999 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-05183
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 14, 2016
    Report Date
    July 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BIOMET CC I-BEAM TRAY 75MM, CATALOG # 141224, LOT # UNKNOWN; SERIES A PAT THIN 37X8.6 3 PEG, CATALOG # 184788, LOT # UNKNOWN; VNGD CR TIB BRG 71/75 X 13 CATALOG # EP-183443 LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-05185. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT MANIPULATION DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602789 VANGUARD CR FEMORAL KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention