BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60MM HEAD HIP MOLD W/INSERT

    MDR report key: 3140198 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01750
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK080979
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POTENTIAL ADVERSE EFFECTS, NUMBER 5 STATES, "DISLOCATION HAS BEEN REPORTED WITH TWO-STAGE REVISIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01750 / 01751).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION OF COMPETITOR PRODUCT ON (B)(6) 2013, DUE TO INFECTION WHEN A BIOMET SELECT 1 SPACER MOLD WAS IMPLANTED. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013, DUE TO DISLOCATION OF THE HEAD AND DISASSOCIATION OF THE TAPER. THE STEM, TAPER AND HEAD WERE REMOVED AND REPLACED WITH BIOMET HEAD, CUP, LINER AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242299 60MM HEAD HIP MOLD W/INSERT PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 982410

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R