BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD STD

    MDR report key: 3963645 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06496
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION REGARDING THE HOSPITAL ADDRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(4) 2013. SUBSEQUENTLY, INFECTION WAS NOTED ON (B)(4) 2013 DUE TO A NON-HEALING SURGICAL WOUND. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442209 36MM COCR MOD HD STD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 602890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R