BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM -4 V40 TAPER VIT HEAD

    MDR report key: 3023839 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01112
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ELEVATED BLOOD METAL LEVELS INVOLVING A 28MM -4 V40 TAPER VIT HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS COMPLETED AND CONCLUDED: "ISSUE WITH CONCERN OVER ELEVATED BLOOD COBALT LEVELS SOME 5½-YEARS POST IMPLANTATION IN A (B)(6) FEMALE PATIENT WITH NEAR NORMAL BODY WEIGHT AND BILATERAL SYMAX STEM PLUS CEMENTLESS CUP IMPLANTATION. PATIENT ACQUIRED LEUKEMIA RECENTLY AND HAD SOME CONCERN OVER A POSSIBLE RELATIONSHIP BETWEEN THE TWO. X-RAYS CONFIRM A BILATERAL SYMAX WITH TRIDENT CUP IMPLANTATION IN ADEQUATE SIZE AND POSITION PLUS STABLE FIXATION IN THE BONE. COMPONENTS REMAIN TO BE IMPLANTED. THE REPORTED SYSTEMIC COBALT LEVELS BETWEEN 2,4 AND 1,6 UG/L ARE HIGHER THAN THE NORMAL REFERENCE FOR A NON-ARTHROPLASTY POPULATION BUT ARE CERTAINLY WITHIN THE NORMAL RANGE FOR AN ARTHROPLASTY POPULATION ESPECIALLY FOR BILATERAL CASES. THE CURRENTLY REPORTED LEVELS ARE NOT EXPECTED TO CAUSE SOFT TISSUE TROUBLE OR OTHER PROBLEMS IN THE ARTHROPLASTY AS ALSO SUPPORTED BY THE NORMAL RADIOLOGY FINDINGS. FOLLOWING INTERNATIONAL AND (B)(4) GUIDELINES THERE IS NO REASON FOR CONCERN OR SPECIAL REQUIREMENTS FOR INVESTIGATION OR FOLLOW-UP. CARCINOGENICITY OF COBALT IONS HAS NOT BEEN REPORTED WITH ARTHROPLASTY COMPONENTS. AS SUCH, BOTH PI CASES (B)(4) ARE PROCEDURE-RELATED AND ARE NOT ASSOCIATED WITH ANY DEVICE-RELATED PROBLEM." A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE MEDICAL REVIEW COMPLETED CONCLUDED THAT THE REPORTED ELEVATED BLOOD METAL LEVELS ARE NOT ASSOCIATED WITH ANY DEVICE-RELATED PROBLEM. THE REPORTED COBALT LEVELS ARE NOT EXPECTED TO CAUSE SOFT TISSUE TROUBLE OR OTHER PROBLEMS IN THE ARTHROPLASTY (SUPPORTED BY THE NORMAL RADIOLOGY FINDINGS) AND WERE BELOW 7 UG/L. THE (B)(4) CONSIDERS A BLOOD COBALT AND CHROME LEVEL BELOW 7 UG/L AS NORMAL AND NOT AN INDICATION FOR FURTHER INVESTIGATION IN THE ABSENCE OF COMPLAINTS.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED IN 2009, THE PATIENT HAD A TOTAL HIP IMPLANTATION (TRIDENT POLYETHYLENE INSERT, SYMAX STEEL AND METAL HOWMEDICA CUP). AFTER IMPLANTATION, THE PATIENT GOT LEUKAEMIA. TESTS OF METAL IONS WERE MADE AND IT WAS OBSERVED THAT COBALT RAISED UP TO 42. AFTER 6 WEEKS, IT REDUCED TO 32.

    Description of Event or Problem · 1

    THE SURGEON REPORTED IN 2009, THE PATIENT HAD A TOTAL HIP IMPLANTATION (TRIDENT POLYETHYLENE INSERT, SYMAX STEEL AND METAL HOWMEDICA CUP). AFTER IMPLANTATION, THE PATIENT GOT LEUKAEMIA. TESTS OF METAL IONS WERE MADE AND IT WAS OBSERVED THAT COBALT RAISED UP TO 42. AFTER 6 WEEKS, IT REDUCED TO 32.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125089 28MM -4 V40 TAPER VIT HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 30557504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other