BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT CEMENTED STEM SZ3 STD

    MDR report key: 2924593 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11275
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK013352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT HAD PRIMARY SURGERY IN THE MORNING, AND LATER THAT EVENING, SHE WAS REVISED DUE TO PERFORATION OF THE CORTEX. ADDITIONAL INFORMATION RECEIVED ALSO MENTIONED INFECTION, BUT THE SURGEON DID NOT BELIEVE THE IMPLANTS TO BE THE SOURCE. (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. AN X-RAY WAS RECEIVED WITH THE INITIAL REPORTING CONFIRMING THE REPORT BUT NOT CONCLUSIVELY DETERMINING ROOT CAUSE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO FURTHER 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT HAD PRIMARY SURGERY IN THE MORNING, AND LATER THAT EVENING, SHE WAS REVISED DUE TO PERFORATION OF THE CORTEX. ADDITIONAL INFORMATION RECEIVED ALSO MENTIONED INFECTION, BUT THE SURGEON DID NOT BELIEVE THE IMPLANTS TO BE THE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30835 SUMMIT CEMENTED STEM SZ3 STD FEMORAL HIP STEM JDI JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. D12101253

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention