BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 14D-SML

    MDR report key: 3070561 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-15688
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. IT IS NOTED THAT THESE DEPUY FEMORAL DEVICES WERE IMPLANTED WITH COMPETITOR MANUFACTURED ACETABULAR DEVICES. THIS IS NOT RECOMMENDED USE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. THE STEM APPEARED TO BE UNDERSIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172769 S-ROM*SLEEVE PRX ZTT, 14D-SML FEMORAL HIP STEM ACCESSORY LPH 9616671 DEPUY (IRELAND) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention