BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 3092593 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01537
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS NOT PERFORMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION NOT PERFORMED BECAUSE NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT:CATALOG # PRODUCT DESCRIPTION LOT #6021-0230 ACCOLADE PLUS TMZF HIP STEM #2 21003901502-11-50D TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL 225211016260-9-132 32MM STD LFIT V40 HEAD 211123012030-6530-1 6.5 CANCELLOUS BONE SCREW 30MM VRRMJD2030-6530-1 6.5 CANCELLOUS BONE SCREW 30MM VT0MJDIT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : NOT RETURNED TO THE MANUFACTURER

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193930 TRIDENT 10° X3 INSERT 32MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 9AXMJD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention