BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 3230932 · Received July 17, 2013

    Report

    Report Number
    1818910-2013-21396
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    August 17, 2011
    Report Date
    July 15, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. A PREVIOUS REVIEW OF PROVIDED PATIENT X-RAYS AND MEDICAL RECORDS DID NOT IDENTIFY PRODUCT ERROR REGARDING THE PATIENT DISLOCATION. THE INVESTIGATION COULD NOT 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 OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REASON FOR ORIGINAL COMPLAINT. CLINICAL REPORT STATES: DISLOCATION REOCCURRENCE. **UPDATE** (B)(4) 2013 - THE COMPLAINT HAS BEEN REOPENED BECAUSE THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332211 DLT TS CER HD 12/14 36MM +5.0 FEMORAL HEAD LZO 8010379 DEPUY INTL., LTD. 3246211

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention