BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX60MM

    MDR report key: 3180769 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02077
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 16, 2013
    Report Date
    August 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION MAY LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02077 / 02078).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02077 / 02078).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO ADVERSE REACTION TO METAL DEBRIS AND ANTEVERSION OF SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ADVERSE REACTION TO METAL DEBRIS AND ANTEVERSION OF SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280935 M2A 1 PC SHELL 38MMX60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 092050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R