BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 S

    MDR report key: 12127883 · Received July 7, 2021

    Report

    Report Number
    3010536692-2021-00362
    Event Type
    Injury
    Date Received
    July 7, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    UDI-DI
    M684PHA044201
    PMA / PMN Number
    K130376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. THESE CERAMIC COMPONENTS WERE REVISED APPROXIMATELY 2-3 WEEKS AFTER THE PRIMARY OPERATION DUE TO INFECTION. THE REVISED PRODUCTS WERE NOT RETURNED FOR INVESTIGATION. NO OPERATIVE NOTES OR OTHER CLINICALLY RELEVANT DOCUMENTATION HAS BEEN PROVIDED TO CONFIRM THIS COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT INDICATES THAT THIS PRODUCT MET ALL ACCEPTANCE CRITERIA AT THE TIME OF MANUFACTURING. INFECTION IS A KNOWN RISK OF ANY SURGICAL PROCEDURE. THE SOURCE OF THE INFECTION CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE MICROPORT HIP SYSTEMS PACKAGE INSERT (150803-8) LISTS "DELAYED WOUND HEALING; DEEP WOUND INFECTION (EARLY OR LATE) WHICH MAY NECESSITATE REMOVAL OF THE PROSTHESIS. ON RARE OCCASIONS, ARTHRODESIS OF THE INVOLVED JOINT OR AMPUTATION OF THE LIMB MAY BE REQUIRED" AS POTENTIAL ADVERSE EFFECTS OF TOTAL HIP ARTHROPLASTY (THA). THERE WERE NO TRENDS IDENTIFIED PER MPO TRENDING PROCEDURES. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT TRACKING.

    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 ID: PHA06266 / LOT NO.: 1851198. PROFEMUR TL CLASSIC FIXED NECK SIZE 6 / PRODUCT ID: PRTLS026 / LOT NO.: 1832007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023103 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 S HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. PHA04420 1815691 M684PHA044201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention