BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3093587 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01562
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    January 23, 2009
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN STRYKER TRIDENT PSL HA 52MM ACETABULAR SHELL. ADDITIONAL DEVICES LISTED IN THIS REPORT: UNKNOWN ALUMINA CERAMIC ACETABULAR INSERT. UNKNOWN RIGHT SECURE FIT HA STEM. UNKNOWN ALUMINA HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND DISLOCATION INVOLVING AN UNKNOWN ACETABULAR SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MAUDE REPORT (B)(4): TOTAL LEFT HIP ARTHROPLASTY/TOTAL RIGHT HIP ARTHROPLASTY. BOTH HIPS HAVE HAD SEVERE PAIN IN GROIN AREA AND NEAR/AROUND SURGICAL AREA. CANNOT LIFT LEFT LEG TO GET INTO A VEHICLE WITHOUT MANUAL HELP (PHYSICALLY LIFT WITH HANDS). CANNOT WALK UP OR DOWN STAIRS WITHOUT A GREAT DEAL OF PAIN IN FEMUR AREA AND GROIN AREA OR BOTH LEGS. CANNOT SIT, STAND, OR WALK FOR A PERIOD OF TIME. THIS OPERATION WAS SUPPOSED TO MAKE ME MOBILE AGAIN SO I COULD RETURN TO WORK. I AM NOT ON DISABILITY AND MY QUALITY OF LIFE IS NOW JUST EXISTING. I HAVE BECOME ALLERGIC TO MY PAIN MEDICINE AND AM LEFT TO DEAL WITH IT BECAUSE MEDICINE WILL NOT COVER OTHER FORMS OF PAIN KILLERS SUCH AS PAIN PATCHES. I HAVE HAD SEVERAL X-RAYS, MRI AND CT SCANS AND THEY ALL SHOW NOTHING WRONG. HAVE BEEN TO OTHER SPECIALISTS FOR 2ND AND 3RD OPTIONS. THEY ALSO COULD NOT FIND ANYTHING WRONG. I SAY THAT YOU CAN'T SEE A JOINT POPPING IN AND OUT OF THE SOCKET WHEN YOU ARE LAYING STILL. THE LEFT ONE POPS AND THE RIGHT ONE HAS DISLOCATED ON TWO OCCASIONS BUT HAS REPOSITIONED ITSELF BEFORE I REACHED THE ORTHOPEDICS OFFICE AND HAS "GIVEN OUT" ON FOUR OTHER OCCASIONS WITH FALLING DOWN STAIRS TWICE; INTO A WINDOW ONCE; AND JUST WALKING ACROSS THE FLOOR SPILLING HOT COFFEE ALL OVER MY DAUGHTER'S WHITE DOG AND RUG. IT HAS BEEN AN EVERYDAY STRUGGLE AND I AM SURE I WILL REMEMBER MORE EVENTS IF THEY ARE NEEDED. EVERYTHING IS DOCUMENTED IN MY MEDICAL REPORTS WITH MY SURGEON AND MY FAMILY PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MAUDE REPORT MW5029410: TOTAL LEFT HIP ARTHROPLASTY/TOTAL RIGHT HIP ARTHROPLASTY. BOTH HIPS HAVE HAD SEVERE PAIN IN GROIN AREA AND NEAR/AROUND SURGICAL AREA. CANNOT LIFT LEFT LEG TO GET INTO A VEHICLE WITHOUT MANUAL HELP (PHYSICALLY LIFT WITH HANDS). CANNOT WALK UP OR DOWN STAIRS WITHOUT A GREAT DEAL OF PAIN IN FEMUR AREA AND GROIN AREA OR BOTH LEGS. CANNOT SIT, STAND, OR WALK FOR A PERIOD OF TIME. THIS OPERATION WAS SUPPOSED TO MAKE ME MOBILE AGAIN SO I COULD RETURN TO WORK. I AM NOT ON DISABILITY AND MY QUALITY OF LIFE IS NOW JUST EXISTING. I HAVE BECOME ALLERGIC TO MY PAIN MEDICINE AND AM LEFT TO DEAL WITH IT BECAUSE MEDICINE WILL NOT COVER OTHER FORMS OF PAIN KILLERS SUCH AS PAIN PATCHES. I HAVE HAD SEVERAL X-RAYS, MRI AND CT SCANS AND THEY ALL SHOW NOTHING WRONG. HAVE BEEN TO OTHER SPECIALISTS FOR 2ND AND 3RD OPTIONS. THEY ALSO COULD NOT FIND ANYTHING WRONG. I SAY THAT YOU CAN'T SEE A JOINT POPPING IN AND OUT OF THE SOCKET WHEN YOU ARE LAYING STILL. THE LEFT ONE POPS AND THE RIGHT ONE HAS DISLOCATED ON TWO OCCASIONS BUT HAS REPOSITIONED ITSELF BEFORE I REACHED THE ORTHOPEDICS OFFICE AND HAS "GIVEN OUT" ON FOUR OTHER OCCASIONS WITH FALLING DOWN STAIRS TWICE; INTO A WINDOW ONCE; AND JUST WALKING ACROSS THE FLOOR SPILLING HOT COFFEE ALL OVER MY DAUGHTER'S WHITE DOG AND RUG. IT HAS BEEN AN EVERYDAY STRUGGLE AND I AM SURE I WILL REMEMBER MORE EVENTS IF THEY ARE NEEDED. EVERYTHING IS DOCUMENTED IN MY MEDICAL REPORTS WITH MY SURGEON AND MY FAMILY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197281 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other