BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 4863485 · Received June 23, 2015

    Report

    Report Number
    0002249697-2015-02043
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT OR REPORTED STERILE LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PATHOLOGY REPORT, X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. IF ADDITIONAL INFORMATION BECOMES 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES REPORTED: CAT # 6570-0-136, LOT # 50806501, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/0 CAT # 6721-0535, LOT # 50447304, DESCRIPTION: SIZE 5 ACCOLADE II 127 DEG, CAT # 542-11-50E, LOT # 6L16YP, DESCRIPTION: TRIDENT PSL HA CLUSTER 50MM, CAT # 2030-6530-1, LOT # MNM1LM, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 30MM. 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

    IT WAS REPORTED THAT THE COMPONENTS WERE EXPLANTED DUE TO INFECTION OF THE RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPONENTS WERE EXPLANTED DUE TO INFECTION OF THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405300 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH XM85M8

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R