BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3935716 · Received July 15, 2014

    Report

    Report Number
    0001825034-2014-06181
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06180 / 06181).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, INFECTION WAS NOTED. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. SUBSEQUENTLY, PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2009 AND IN (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. DURING POST-OPERATIVE MONITORING, INFECTION WAS NOTED. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP MONITORING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. SUBSEQUENTLY, PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2009 AND IN (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412019 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 346350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R