BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 3093339 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-16529
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED PRODUCT/LOT COMBINATION DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE REMAINING PRODUCTS AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS (B)(6) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197396 DELTA CER HEAD 12/14 36MM +1.5 FEMORAL HEAD LZO 9616671 DEPUY (IRELAND) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention