BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 5720981 · Received June 13, 2016

    Report

    Report Number
    0002249697-2016-01929
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 16, 2016
    Report Date
    May 16, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO INFORMATION WAS RECEIVED FOR REVIEW WITH THE CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR RELEVANT EVENTS FOR THE REPORTED LOTS OR STERILE LOTS. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE,PATHOLOGY REPORTS, OPERATIVE REPORTS, XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 6570-0-128, LOT # 53922204, DESCRIPTION: DELTA V-40 CERAMIC HEAD 28/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    RIGHT HIP IND FOR INFECTION. NO RETURN DUE TO HOSPITAL POLICY. NO MEDICAL RECORDS, X-RAY OR FUTHER INFORMATION DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 1

    RIGHT HIP IND FOR INFECTION. NO RETURN DUE TO HOSPITAL POLICY. NO MEDICAL RECORDS, X-RAY OR FURTHER INFORMATION DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376302 RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH 52984101

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R