BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML LG STATURE 13.5MM

    MDR report key: 3150787 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18332
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK012364
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE CORRECTION. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250753 AML LG STATURE 13.5MM HIP STEM LPH DEPUY ORTHOPAEDICS, INC. - 1818910 BD3A31000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention