BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT X3 ELEVATED RIM 36MM ID

    MDR report key: 4322534 · Received December 11, 2014

    Report

    Report Number
    0002249697-2014-04619
    Event Type
    Injury
    Date Received
    December 11, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: UNK, UNKNOWN ACCOLADE 2.5 STEM, LOT CODE: UNKNOWN. CAT. NO.: 18-3675, DELTA C-TAPER HEAD 36MM +7.5, LOT CODE: 40532401. CAT. NO.: 542-11-54F, TRIDENT PSL HA CLUSTER 54MM, LOT CODE: UNKNOWN. CAT. NO.: 17-0000E, TI SLEEVE FOR ALUMINA HEAD, LOT CODE: MLP5A7. CAT. NO.: 2030-6520-1, 6.5 CANCELLOUS BONE SCREW 20MM LOT CODE: UNKNOWN. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: EXPLANTATION DAMAGE WAS IDENTIFIED ON THE RETURNED DEVICE. A SCREW WAS USED TO SEPARATE THE LINER FROM THE SHELL. NO FURTHER DAMAGE WAS IDENTIFIED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED THAT: "THERE IS NO CLINICAL INFORMATION ON FURTHER RECONSTRUCTIVE OR OTHER PROCEDURES PERFORMED IN THIS CASE, NEITHER ON CLINICAL OUTCOME. SO, OUTCOME IS UNDETERMINED SO FAR. IN THIS CASE NO CORRELATION BETWEEN ANY SPECIFIC DEVICE PROPERTY AND INFECTION CAN BE ESTABLISHED. PATIENT HAD MAINLY BAD LUCK TO BELONG TO THE SMALL PERCENT CATEGORY OF INFECTIOUS ARTHROPLASTY COMPLICATIONS. AS SUCH, THIS PI CASE IS CAUSED BY A MIX OF ADVERSE PATIENT-RELATED AND PROCEDURE-RELATED FACTORS. THERE ARE NO DEVICE-RELATED FACTORS ACTIVE IN THIS CASE AND THIS PI IS NOT DEVICE-RELATED." 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 EVENTS FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED THAT THE EVENT WAS NOT DEVICE RELATED. THE EXACT CAUSE OF THE EVENT HOWEVER COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, OPERATIVE REPORTS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT HIP REVISION DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT HIP REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805797 TRIDENT X3 ELEVATED RIM 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMP18E

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention