BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 3241446 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02827
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    November 23, 2004
    Report Date
    June 24, 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
    OH, 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 POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02827 / 02828).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. A SUBSEQUENT REVISION OF THE LEFT HIP WAS PERFORMED ON (B)(6) 2004 DUE TO DISLOCATION. THE CUP WAS REMOVED AND REPLACED WITH A CUP AND LINER. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341533 M2A 38MMX52MM CUP PROTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 109490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R