BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP SYSTEM

    MDR report key: 2960439 · Received February 7, 2013

    Report

    Report Number
    1226188-2013-00006
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. LOT NUMBERS OF THE IMPLANTED PRODUCTS WERE NOT RECORDED ON THE INVOICE FOR THE ORIGINAL IMPLANT SURGERY, SO ALL LOT RECORDS OF THE PRODUCT RELEASED AT THE TIME OF THE SURGERY WERE REVIEWED. THERE WERE TWO LOTS OF THE MODULAR STEMS RELEASED AT THE TIME OF THE ORIGINAL SURGERY, LOT NUMBER: 064 AND 102. ONE LOT WAS ACCEPTED ON A DEVIATION REQUEST THAT WAS UNRELATED TO THE PIN ASSEMBLY OF THE MODULAR STEM. THE SECOND LOT WAS ACCEPTED NO DEVIATIONS. PIN SHEAR IS A KNOWN ISSUE, SEE ATTACHED TECHNICAL REPORT. THERE HAVE BEEN NO PIN FAILURES DUE TO PIN SHEAR SINCE THE REDESIGN IN JUNE 2004.

    Description of Event or Problem · 1

    SURGEON REPORTED A SUSPECTED APEX STEM FAILURE (SMALL PIN FAILURE). INITIAL SURGERY WAS ON (B)(6) 2001 AND REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51406 APEX MODULAR HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNLIFE SCIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R