BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 4122849 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03622
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 12, 2007
    Report Date
    September 4, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 500-01-52E TRIDENT HEMISPHERICAL SOLID BK 52MM LOT CODE 19649801. CAT 6265-1-006 MERIDIAN TMZF STEM #3/11MM LOT CODE 21983902. CAT 6570-0-136 DELTA V-40 CERAMIC HEAD 36/0 LOT CODE 22256901. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING CUP LOOSENING INVOLVING A TRIDENT 10° X3 INSERT 36MM ID WAS REPORTED. CONCLUSION: AS PER MEDICAL RECORDS REVIEW PATIENT WAS REVISED DUE TO ACETABULAR LOOSENING. NO ALLEGATIONS WERE MADE REGARDING THE INSERT. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION SURGERY INVOLVING A TRIDENT 10° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿X-RAY COPY AVAILABLE FOR REVIEW IS AN UNDATED AP OF THE PELVIS DEMONSTRATING BILATERAL TOTAL HIP ARTHROPLASTIES [¿] LEFT HYBRID TOTAL HIP ARTHROPLASTY WITH RADIOLUCENCIES AROUND ALL THREE ZONES OF THE ACETABULUM AND AROUND THE FEMORAL COMPONENT CEMENT/BONE INTERFACES. THERE ARE NO OPERATIVE REPORTS FOR THE PRIMARY OR FIRST REVISION LEFT TOTAL HIP ARTHROPLASTY AND NO EXAMINATION OF EXPLANTED COMPONENTS AVAILABLE.¿ -DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODE WAS IDENTIFIED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW WITH CLINICAL CONSULTANT AND NO DEVICES WERE RETURNED. FURTHER INFORMATION SUCH AS DATED PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY AND REVISION OPERATIVE REPORT ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A HIP DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A HIP DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A HIP DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600713 TRIDENT 10° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 7E4MJD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention