BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD -3MM NK

    MDR report key: 4100009 · Received September 18, 2014

    Report

    Report Number
    0001825034-2014-07803
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A 522 POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. PATIENT ALLEGES STIFFNESS, PAIN, LIMP, WEAKNESS AND LOSS OF RANGE OF MOTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578275 32MM M2A MOD HEAD -3MM NK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 508080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention