BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM SLEEVE PRX ZTT, 16D-SML

    MDR report key: 1852090 · Received September 28, 2010

    Report

    Report Number
    1818910-2010-06424
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    DEPUY INTL LTD
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MFG DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    STEM SAT PROUD AFTER SPLINES ENGAGED, CAUSING A DELAY IN SURGERY OF 1 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SLEEVE PRX ZTT, 16D-SML LPH DEPUY INTL LTD NA 3076984

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR