BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX AUGMENT 52MM SM

    MDR report key: 3223787 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02663
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 8, 2013
    Report Date
    October 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PK052888
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE FOUND EVIDENCE THAT SUGGESTS FAILURE MODE WAS DUE TO OVERLOAD DURING INSERTION. THIS CAN BE CAUSED BY MISALIGNMENT OF THE SCREWS DURING IMPLANTATION.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS STATES, ¿IMPROPER PREOPERATIVE OR INTRAOPERATIVE IMPLANT HANDLING OR DAMAGE (SCRATCHES, DENTS, ETC.) CAN LEAD TO CREVICE CORROSION, FRETTING, FATIGUE FRACTURE AND/OR EXCESSIVE WEAR.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON IMPLANTED AN AUGMENT THEN DISCOVERED THAT IT WAS FRACTURED AND LOOSE. THE SURGEON REMOVED THE AUGMENT AND COMPLETED THE PROCEDURE WITHOUT IT. THERE WAS A DELAY IN THE PROCEDURE GREATER THAN THIRTY MINUTES. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324421 REGENEREX AUGMENT 52MM SM PROSTHESIS, HIP MEH BIOMET ORTHOPEDICS N/A 508110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R