BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M

    MDR report key: 11301192 · Received February 9, 2021

    Report

    Report Number
    3010536692-2021-00064
    Event Type
    Injury
    Date Received
    February 9, 2021
    Report Date
    February 9, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    UDI-DI
    M684PHA044221
    PMA / PMN Number
    K130376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED : PROCOTYL L BEADED AND HA COATED CUP SIZE 56MM, PRODUCT NUMBER: PHA06266, LOT NUMBER: 1816180. PROFEMUR TL CLASSIC FIXED NECK SIZE 7 PRODUCT NUMBER: PRTLS027, LOT NUMBER: 1832175, MHRA REFERENCE NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197330 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. PHA04422 1811985 M684PHA044221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention