BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B HI 80MM

    MDR report key: 3879275 · Received June 18, 2014

    Report

    Report Number
    0001825034-2014-05577
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 5, 2014
    Report Date
    May 6, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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/OR ALLERGIC REACTION.¿ NUMBER 8 STATES, " DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 11 OF 12 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05567 / 05578).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 11 OF 14 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05567 / 05538 & 2016-01939 / 01940).

    Description of Event or Problem · 1

    IT WAS REPORTED IN OPERATIVE NOTES RECEIVED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE FIFTEEN (15) DAYS POST-IMPLANTATION DUE TO INFECTION, FRACTURE EXTENSION AND LOOSENING OF COMPETITOR PLATE AND SCREWS. DURING THE PROCEDURE, DRAINING SINUS, A SEROMA AND NECROTIC TISSUE WERE NOTED. THE MODULAR HEAD AND PROXIMAL FEMORAL COMPONENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY WITH COMPETITOR PRODUCTS ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED TO A BIOMET TOTAL HIP ON (B)(6) 2013. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, DUE TO A FEMORAL FRACTURE, A FRACTURED SYNTHES PLATE AND INFECTION. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. ON (B)(6) 2014, PATIENT WAS REVISED DUE TO DISLOCATION AND UNDERWENT IRRIGATION AND DEBRIDEMENT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358639 ARCOS CON SZ B HI 80MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 388890

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R