BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 56MM

    MDR report key: 3951125 · Received July 22, 2014

    Report

    Report Number
    0001825034-2014-06374
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    May 23, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06374 AND 06375).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND A VERTICALLY POSITIONED CUP. DURING THE PROCEDURE, THE MODULAR HEAD AND ACETABULAR CUP WAS REMOVED AND REPLACED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, A REVISION INVOICE COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427964 M2A-38 CUP NON FLARED SZ 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 087070

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R