BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 1

    MDR report key: 4093897 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03498
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN EXETER V40 STEM 44MM NO 1 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATIONS. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, MEDICAL RECORDS, AND X-RAYS IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE MHRA, THAT A REVISION CASE TOOK PLACE ON (B)(6) 2014 OF A LEFT HIP ON A(B)(6) PATIENT (DOB (B)(6) ). THE PRIMARY CASE TOOK PLACE ON (B)(6) 2006. THE CUSTOMER HAS REPORTED THAT THE PRIMARY CASE TOOK PLACE AS THE PATIENT WAS SUFFERING FROM OSTEOARTHRITIS. THE CUSTOMER HAS REPORTED THAT THE REVISION CASE WAS REQUIRED DUE TO LOOSENING OF FEMORAL AND ACETABULAR COMPONENTS. THE CUSTOMER HAS REPORTED THAT THE COMPONENTS FOR THE PRIMARY CASE WERE MADE UP OF AN EXETER V40 STEM, AN EXETER V40 HEAD AND A DEPUY ELITE PLUS CUP, THE HIP WAS CEMENTED WITH PALACOS CEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE (B)(6), THAT A REVISION CASE TOOK PLACE ON (B)(6) 2014 OF A LEFT HIP ON A (B)(6)PATIENT (DOB (B)(6) 1924). THE PRIMARY CASE TOOK PLACE ON (B)(6) 2006. THE CUSTOMER HAS REPORTED THAT THE PRIMARY CASE TOOK PLACE AS THE PATIENT WAS SUFFERING FROM OSTEOARTHRITIS. THE CUSTOMER HAS REPORTED THAT THE REVISION CASE WAS REQUIRED DUE TO LOOSENING OF FEMORAL AND ACETABULAR COMPONENTS. THE CUSTOMER HAS REPORTED THAT THE COMPONENTS FOR THE PRIMARY CASE WERE MADE UP OF AN EXETER V40 STEM, AN EXETER V40 HEAD AND A DEPUY ELITE PLUS CUP, THE HIP WAS CEMENTED WITH PALACOS CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571305 EXETER V40 STEM 44MM NO 1 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G1407082

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention