BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM HEXLOC 28 10DEG W/HWL A

    MDR report key: 4620813 · Received March 20, 2015

    Report

    Report Number
    0001825034-2015-01076
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    February 24, 2015
    Report Date
    April 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 1825034-2015-00545.

    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: "IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-01076 & 01077).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO POLY WEAR. THE LINER WAS REMOVED AND REPLACED. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2015 DUE TO PAIN AND OSTEOLYSIS BEHIND THE CUP. THE CUP, LINER, AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190299 ARCOM HEXLOC 28 10DEG W/HWL A PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 308120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R