BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM NON-FLARED ONE-PIECE CUP 38MM I.D. X 56MM O.D.

    MDR report key: 2172096 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00585
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    August 10, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED. THIS REPORT FILED (B)(4), 2011.

    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 DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER "POSSIBLE ADVERSE EFFECTS", NUMBER EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP ARTHROPLASTY ON (B)(6), 2005 DUE TO DISLOCATION. A SUBSEQUENT REVISION SURGERY WAS PERFORMED ON (B)(6), 2011 DUE TO RECURRENT DISLOCATION ADDRESSED WITH CLOSED REDUCTION. THE SURGEON NOTED DURING THE REVISION THAT THE ACETABULAR CUP HAD BEEN PLACED TOO VERTICAL AND THAT THE PATIENT HAD BOTH ANTERIOR AND POSTERIOR INCISIONS. THE MODULAR HEAD WAS REMOVED AND REPLACED WITH AN ACTIVE ARTICULATION ACETABULAR LINER AND MODULAR HEAD. THE ACETABULAR CUP REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2005. SUBSEQUENTLY, PATIENT HAS COMPLAINED OF PAIN AND DISLOCATION WITH SUCCESSFUL CLOSED REDUCTION REPORTED. NO ADDITIONAL REVISION PROCEDURE HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM NON-FLARED ONE-PIECE CUP 38MM I.D. X 56MM O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 381010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R