BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM HEXLOC 28 10DEG W/HWL C

    MDR report key: 3665224 · Received March 6, 2014

    Report

    Report Number
    0001825034-2014-01289
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 1 STATES THE FOLLOWING, "MATERIAL SENSITIVITY REACTIONS" AND "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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01289 AND 1825034-2014-01376).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 1988. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO POLY WEAR AND OSTEOLYSIS. THE FEMORAL AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2014 DUE TO OSTEOLYSIS AND SYNOVITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1988. PATIENT WAS REVISED ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED AGAIN ON (B)(6) 2014 AFTER ALLEGEDLY IDENTIFYING OSTEOLYSIS THROUGH X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134297 ARCOM HEXLOC 28 10DEG W/HWL C PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 358780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R