BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3319233 · Received August 30, 2013

    Report

    Report Number
    0002249697-2013-02890
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    March 1, 2011
    Report Date
    August 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER RIGHT HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ON AUG 5, 2014 MAUDE REPORT # MW5036803 WAS RECEIVED BY STRYKER. THE RECEIVED INFORMATION ALONG WITH PREVIOUSLY RECEIVED DEVICE INFORMATION CONFIRMED THAT REPORTED EVENT IS RELATED TO CORIN LTD PRODUCT NOT A STRYKER ORTHOPAEDICS PRODUCT. THE FOLLOWING DEVICE INFORMATION WAS RECEIVED: CORMET HEAD - SIZE 4/44MM; CAT# 571-04-044; LOT# LFHQ; CORMET CUP - SIZE 4/50MM (ID 44MM); CAT# 570-04-050; LOT# LQVQ. THE MANUFACTURER WHO IS RESPONSIBLE FOR REGULATORY REPORTING HAS BEEN NOTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN, HAS COMPLAINTS OF HIP POPPING IN AND OUT OF PLACE, AND METAL TASTE IN MOUTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN, HAS COMPLAINTS OF HIP POPPING IN AND OUT OF PLACE, AND METAL TASTE IN MOUTH. MAUDE REPORT # MW5036803 STATED: "VOLUN 27-JUN-2014: I HAD THE CORIN-CORMET METAL ON METAL HIP RESURFACING IMPLANT SURGERY IN (B)(6) 2011. IT DID NOT WORK FROM DAY ONE. REALLY GOT SICK PHYSICALLY AND MENTALLY. I ENDED UP HAVING A TOTAL CERAMIC AND WHATEVER, DONE IN (B)(6) 2013. I LOST EVERYTHING BECAUSE OF THE METAL ON METAL RESURFACING. MY HOUSE IS GONE, MY JOB (HAD TO RETIRE AT (B)(6) WENT FOR A YEAR BEFORE I RETIRED WITH NO MONEY COMING IN), NO INSURANCE, LOTS OF DEBT AND NOW WILL BE WITHOUT A CAR, BECAUSE YOU PEOPLE WILL NOT RECALL THAT STUPID IMPLANT. WHAT DO US POOR PEOPLE WHO WORKED HARD ALL THEIR LIVES, RAISE 3 CHILDREN (EVEN WITH A DIVORCE), NEVER LIVED ON ANY GOVERNMENT SUPPORT, DO WITH NOTHING AND A LOT OF ACHES AND PAIN AND LACK OF SOME MOBILITY. I DO KNOW THERE ARE A LOT OF PEOPLE OUT THERE THAT ARE SUFFERING THE SAME BECAUSE OF THE IMPLANT. WHAT MORE CAN WE DO? I ALSO KNOW THAT THERE ARE LITIGATIONS BEING DONE IN (B)(6) AND ELSEWHERE ON THE CORIN-CORMET METAL ON METAL HIP RESURFACING IMPLANT. DOES SOMEONE HAVE TO DIE BECAUSE OF THE REACTIONS AND BAD EFFECTS OF THIS? LIKE (B)(6) LET IT GO AND SEE WHAT ELSE WILL HAPPEN BECAUSE IT'S TOO COSTLY TO RECALL. I RECEIVED A WARNING LETTER FROM (B)(6), WHO HAD BEEN NOTIFIED BY YOU PEOPLE ABOUT THE BAD REACTIONS AND EFFECTS OF THIS IMPLANT. I CONTACTED MY DOCTOR RIGHT AWAY WHEN I RECEIVED THE LETTER IN (B)(6) OF 2013. TOOK X-RAYS AND SURE AS HECK IT HAD TOTALLY LOOSENED, FLAKED, POP IN AND OUT AND HAD FAILED, WITH A LOT OF PAIN WITH IT. I LOST MY MUSCLE WHICH HAD ATROPHIED, MY OTHER HIP NOW IS BAD, AND ALMOST LOST MOST OF MY MOBILITY. WHAT MORE DO YOU NEED? NO LAWYERS WILL TAKE THIS BECAUSE OF YOUR APPROVAL AND THE PMA, WHICH THEY DID RATHER UNDERHANDED. I HAVE ALWAYS BEEN INDEPENDENT AND COULD PAY MY BILL, NOW I CAN'T, EVEN WITH (B)(6) THAT I GOT AFTER 2 YEARS OF FAILURE. I BELIEVE IT SHOULD BE ADDRESSED, AND I SHOULD BE COMPENSATED FOR NO INSURANCE, LOST WAGES, A LOT OF DEBT, AND PAIN AND SUFFERING FOR 3 YEARS. PLEASE I BEG OF YOU BEFORE IT'S TOO LATE, LOOK INTO THIS. I SEE STRYKER NO LONGER USES THE PARTS THAT I HAD. HOW ABOUT THAT. I ALSO WANT YOU TO KNOW I HAVE CONTACTED MY SENATORS WHO ARE LOOKING INTO THIS ALSO AND MY GOVERNOR. NO ONE SHOULD LOSE EVERYTHING BECAUSE THEY TRUST THEIR DOCTOR AND THE GOVERNMENT ON WHAT GOES INTO YOU. PLEASE CONTACT ME AND LET ME KNOW WHAT IS HAPPENING WITH THIS. I HAVE GONE THROUGH 10 OR MORE LAWYERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429627 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other