BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*HEAD FEMORAL COCR 28+0

    MDR report key: 2915640 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-10958
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK920317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. COMPLIANT TO PART 803.22, DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: SMITH & NEPHEW ACETABULAR IMPLANTS EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION, OSTEOLYSIS, AND LOOSENING OF THE STEM AND SLEEVE DUE TO THE INFECTION. DOI (B)(6) 2012 - DOR (B)(6) 2012 (RIGHT HIP). 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION, OSTEOLYSIS, AND LOOSENING OF THE STEM AND SLEEVE DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22524 S-ROM*HEAD FEMORAL COCR 28+0 FEMORAL HEAD JDI DEPUY INTL., LTD. ¿ REG. # 8010379 3511529

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention