BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM HEXLOC 28 10DEG W/HWL A

    MDR report key: 4513692 · Received February 12, 2015

    Report

    Report Number
    0001825034-2015-00545
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    February 23, 2011
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 RELATED TO THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2015-00544 / 00545).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT AND RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2009 DUE TO UNKNOWN REASONS. BASED ON INVOICE HISTORY, THE LINER WAS REMOVED AND REPLACED. THE PATIENT UNDERWENT A FURTHER RIGHT HIP REVISION ON (B)(6) 2015 DUE TO PAIN AND OSTEOLYSIS. THE HEXLOC CUP, HEXLOC LINER, AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2011 DUE TO UNKNOWN REASONS. ALL PARTS WERE REMOVED AND REPLACED BY A BIOMET STEM, CONSTRAINED HEAD, CONSTRAINED LINER, AND RINGLOC CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO UNKNOWN REASONS. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2011 DUE TO UNKNOWN REASONS. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. AN ADDITIONAL REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104271 ARCOM HEXLOC 28 10DEG W/HWL A PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 308120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R