BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 4140307 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03748
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CORROSION INVOLVING A COCR HEAD WAS REPORTED. THE EVENT ¿TAR-LIKE¿ SUBSTANCE WAS CONFIRMED THROUGH A PROVIDED PHOTOGRAPH ON THE STEM TRUNNION, HOWEVER, CORROSION COULD NOT BE CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A PHOTO OF THE DEVICE SHOWS THE TAR-LIKE SUBSTANCE ON THE STEM TRUNNION. WITHOUT RETURN AND EVALUATION OF THE DEVICE, CORROSION CANNOT BE CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW INDICATED THE SUBSTANCE NOTED IS LIKELY BLOOD CONCENTRATION BUT THIS CANNOT BE CONFIRMED WITHOUT THE DEVICES. RECORDS WERE REVIEWED BY A CONSULTING CLINICIAN CONCLUDING: ¿SCREW REMOVAL REQUIRED REMOVAL OF BOTH LINER AND FEMORAL HEAD AND ALL VISUAL. ASPECTS OF THE OF TAR-LIKE BLACK BAND NEAR THE TRUNNION POINT TO MOST PROBABLY BLOOD CONCENTRATION AS THE NATURE OF THE DISCOLORATION AS CAUSED BY LOCATION BETWEEN FEMORAL HEAD INSIDE TAPER AND STEM NECK WHERE BLOOD RESORPTION IS IMPOSSIBLE. ONLY EXPLANT MATERIALS ANALYSIS COULD PROVE SUCH ALTHOUGH THE CONTEXT OF THE REVISION CASE HAS NO INFORMATION TO SUGGEST THAT ANY SIGNIFICANT TAPER CORROSION HAS PLAYED ANY ROLE IN THE FAILURE SCENARIO. ALSO THE YELLOW DISCOLORATION OF THE POLYETHYLENE LINER SHOULD BE CONSIDERED HARMLESS AND ALSO A SECONDARY FINDING AT LONG TERM IMPLANTATION DUE TO PROTEIN AND BLOOD ABSORPTION INTO THE POLY. BOTH ASPECTS ARE PROCEDURE-RELATED AND BECAUSE ALSO THE ROOT FAILURE CAUSE IS PROCEDURE-RELATED WIT REGARD TO MALPOSITION OF THE BONE SCREW, ALL ASPECTS OF THIS PI CASE ARE PROCEDURE-RELATED WITHOUT INVOLVEMENT OF EITHER PATIENT-RELATED OR DEVICE-RELATED FACTORS. THIS PI CASE IS NOT DEVICE-RELATED.¿ DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICES ARE NEEDED TO INVESTIGATE FOR CORROSION.

    Description of Event or Problem · 1

    PT CAME INTO THEATRE WITH HIP PAIN. PT HAD ACCOALDE TMZF AND TRIDENT CUP IMPLANTED APPROX 8 YEARS AGO. WHEN SURGEON OPENED UP THE PT HE HAD VERY INFLAMED TISSUE. DR TOOK V40 HEAD OFF STEM & THERE WAS BLACK TAR LIKE SUBSTANCE ON THE TRUNNION. DR BELIEVES THIS IS TRUNNIONOSIS. ALSO THE POLY WAS YELLOW. DR REPLACED LINER AND HEAD WITH X3 LINER AND NEW LFIT V40 FEMORAL HEAD.

    Description of Event or Problem · 1

    PT CAME INTO THEATRE WITH HIP PAIN. PT HAD ACCOALDE TMZF AND TRIDENT CUP IMPLANTED APPROX 8 YEARS AGO. WHEN SURGEON OPENED UP THE PT HE HAD VERY INFLAMED TISSUE. DR TOOK V40 HEAD OFF STEM & THERE WAS BLACK TAR LIKE SUBSTANCE ON THE TRUNNION. DR BELIEVES THIS IS TRUNNIONOSIS. ALSO THE POLY WAS YELLOW. DR REPLACED LINER AND HEAD WITH X3 LINER AND NEW LFIT V40 FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617907 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 32729304

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention