BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 32MM +3

    MDR report key: 3040509 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15037
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY IRELAND ? REG. # 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD FOR THE HEAD REVEALED NO MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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. 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.

    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

    CLINICAL REPORT STATES THE PATIENT HAD POLYWEAR OF THEIR LINER. THEY HAD LATE INSTABILITY AND DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142975 DELTA CER HEAD 11/13 32MM +3 HEAD LZO DEPUY IRELAND ? REG. # 9616671 1821316

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention