BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 48MM

    MDR report key: 3829945 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04749
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 OR ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY REVISION DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04749 & 060324).

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT REPORTS ALLEGATIONS OF PAIN, INABILITY TO WALK LONG DISTANCES, NOISES, AND FLUID AROUND THE JOINT. PATIENT FURTHER REPORTS A REVISION HAS BEEN RECOMMENDED. THERE HAS BEEN NO REPORTED REVISION TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT REPORTS A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, INABILITY TO WALK LONG DISTANCES, NOISES, AND FLUID AROUND THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308621 M2A-MAGNUM MOD HEAD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 649070

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R