BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE CTA HD 44X18

    MDR report key: 2821945 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-27417
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 1, 2012
    Manufacturer
    DEPUY SUZHOU
    Product Code
    HSD
    PMA / PMN Number
    K000575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    EXAMINATION OF THE RETURNED DEVICE SHOWS NOTHING OUTWARD TO SUGGEST PRODUCT PROBLEM. IT WAS INITIALLY REPORTED THE PATIENT FELL AFTER IMPLANTATION. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTFIED.DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO HEAD DISASSOCIATION ONLY THE HEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE CTA HD 44X18 DEPUY SHOULDER HEAD IMPLANT HSD DEPUY SUZHOU D11090267

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention