BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A HI CARBON HD STD NK

    MDR report key: 3800885 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03717
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03716/03718).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A REVISION PROCEDURE ON (B)(6) 2014 DUE TO ALLEGED PAIN AND PSEUDOTUMORS. THE ACETABULAR CUP, MODULAR HEAD AND TAPER LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277667 28MM M2A HI CARBON HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 049570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R