BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM +4 V40 TAPER VIT HEAD

    MDR report key: 3123134 · Received May 21, 2013

    Report

    Report Number
    0002249697-2013-01738
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    January 4, 2005
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT IS STILL IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND ALLERGY/REACTION INVOLVING A 28MM +4 V40 TAPER VIT HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION. A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED. ISSUE WITH PAIN AND DIFFICULTY WALKING 9-YEARS POST PRIMARY IMPLANTATION OF AN ACCOLADE TMZF STEM WITH TRIDENT CUP IN A (B)(6) YEAR OLD FEMALE PATIENT WITH NEAR NORMAL BODY WEIGHT. INITIAL X-RAYS WERE REPORTED AS NORMAL BUT IN 2014 SUSPECTED ELEVATED COBALT AND CHROME VALUES IN BLOOD AND URINE WERE REPORTED. NO X-RAYS ARE AVAILABLE FOR REVIEW AND NO IMPLANTS WERE RETURNED FOR INVESTIGATION AS THEY REMAIN TO BE IMPLANTED. SURGICAL REPORT OF PRIMARY ARTHROPLASTY SHOWS NO ISSUES WHILE THE LAB REPORTS SOMEWHAT ELEVATED COBALT AND CHROME LEVELS IN THE PATIENT¿S URINE ALTHOUGH BLOOD CHROME IS NORMAL BUT BLOOD COBALT SLIGHTLY ELEVATED. IN THIS CASE, THERE IS NO REASON FOR CONCERN AS BASED UPON THE OBSERVED METAL ION VALUES. THE REPORTED VALUES ARE VERY MUCH PATIENT-RELATED AND WITHIN THE CONTEXT OF A NON METAL-ON-METAL TYPE OF ARTHROPLASTY PERFECTLY NORMAL. IN CASE OF MECHANICAL DERANGEMENT OF THE ARTHROPLASTY SUCH AS WITH IMPINGEMENT, MALPOSITION, SUBLUXATION AND MORE, ALSO THE METAL ION LEVELS USUALLY GO UP, ESPECIALLY COBALT AND THIS WOULD BE A GOOD GUIDELINE FOR FURTHER FOLLOW-UP. IN THIS CASE, NO SPECIAL CONSIDERATIONS WOULD APPLY AND REGULAR FOLLOW-UP WOULD BE ADEQUATE. AS SUCH THERE IS NO RELATIONSHIP OF THE REPORTED BLOOD METAL ION LEVELS WITH ANY PROCEDURE-RELATED OR DEVICE-RELATED ASPECT OF THE COMPONENTS IN PLACE. THIS PI CASE IS NOT DEVICE-RELATED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE PAIN COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN RIGHT HIP. PATIENT CAN'T HARDLY WALK. PATIENT STATES THAT SHE HAS GONE TO HER SURGEON MANY TIMES FOR X-RAYS. ACCORDING TO THE X-RAYS THE SURGEON SAYS EVERYTHING IS FINE. IN (B)(6) OF 2012 PATIENT STARTED HAVING ELEVATED COBALT AND CHROMIUM LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAS PAIN IN RIGHT HIP. PATIENT CAN'T HARDLY WALK. PATIENT STATES THAT SHE HAS GONE TO HER SURGEON MANY TIMES FOR X-RAYS. ACCORDING TO THE X-RAYS THE SURGEON SAYS EVERYTHING IS FINE. IN (B)(6) OF 2012 PATIENT STARTED HAVING ELEVATED COBALT AND CHROMIUM LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224998 28MM +4 V40 TAPER VIT HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 6028001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other