BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3060551 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01326
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    September 28, 2011
    Report Date
    March 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SUBSIDENCE INVOLVING AN ACCOLADE HIP WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR. THE REPORT INDICATED A "SMALL AMOUNT OF THE HA SPRAYED COATING WAS STILL PRESENT ON THE TI PLASMA SPRAYED COATING" OF THE STEM. IT WAS ALSO NOTED IN THE MAR "THERE ARE SOME MARKS ON THE TRUNNION BY THEY ARE FROM THE IMPLANTATION AND EXPLANTATION PROCESS". THE REPORT CONCLUDED "NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON ANY OF THE SAMPLES EXAMINED". DIMENSIONAL MEASUREMENTS THAT RELATED TO THE REPORTED EVENT WERE CARRIED OUT. ALL RESULTS CONFORMED TO THE SPECIFICATIONS. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "X-RAY COPIES, ALL UNDATED, INCLUDE TWO AP¿S OF THE PELVIS, ONE AP OF THE LEFT HIP, ONE LATERAL OF THE LEFT HIP, AND A SINGLE AP DEMONSTRATING AN UNCEMENTED LEFT TOTAL HIP ARTHROPLASTY WITH ONE SCREW IN THE ACETABULUM. THE HIP IS REDUCED AND THE COMPONENTS ARE IN NOMINAL POSITION. THREE OTHER FILMS DEMONSTRATE SUBSIDENCE OF THE STEM BY APPROXIMATELY 1 CENTIMETER WITH A SURROUNDING RADIOLUCENCY." ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE SUBSIDENCE OF THE STEM IN THIS OBESE, ACTIVE, RELATIVELY YOUNG PATIENT COULD NOT BE DETERMINED, HOWEVER THERE IS NO EVIDENCE THAT IT WAS MATERIAL OR MANUFACTURING RELATED. THERE WAS A SMALL AMOUNT OF THE HA COATING THAT REMAINED ON THE STEM, HOWEVER HA COATING IS VERY STABLE AND IF DOES NOT COME INTO CONTACT WITH BONE THE HYDROXYAPATITE WOULD BE EXPECTED TO REMAIN ON THE TI PLASMA COATED SURFACE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN LEFT UNKNOWN STRYKER 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. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS COMPLAINING OF PAIN ON HIS LEFT SIDE OF HIS HIP. PATIENT IS REPORTING NOT BEING ABLE TO SLEEP DUE TO THE PAIN. PATIENT ALSO COMPLAINS OF PAIN RADIATING DOWN THE LEFT SIDE OF HIS LEG AND THE PAIN HAS BEEN CONTINUOUS SINCE UNDERGOING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS COMPLAINING OF PAIN ON HIS LEFT SIDE OF HIS HIP. PATIENT IS REPORTING NOT BEING ABLE TO SLEEP DUE TO THE PAIN. PATIENT ALSO COMPLAINS OF PAIN RADIATING DOWN THE LEFT SIDE OF HIS LEG AND THE PAIN HAS BEEN CONTINUOUS SINCE UNDERGOING SURGERY. PATIENT HAD A BONE SCAN THAT SHOWED THAT THE IMPLANT SHIFTED 2 CM DOWN CAUSING HIM TO HAVE THE IMPLANT REMOVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163394 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other