BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16D-SML

    MDR report key: 2970956 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-03981
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 ELEVATED COCR LEVELS, ALVAL, CYST WAS PRESENT, ALSO NOTED INTEROPERATIVELY WAS CORROSION AT THE NECK OF THE STEM AND INSIDE THE SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76695 S-ROM*SLEEVE PRX ZTT, 16D-SML SLEEVE LPH DEPUY IRELAND 1867425

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention