BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE CM CEMENTED HIP #2

    MDR report key: 2971641 · Received February 21, 2013

    Report

    Report Number
    0002249697-2013-00734
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING STEM LOOSENING INVOLVING A RELIANCE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AS IT WAS DISCARDED. MEDICAL RECORDS RECEIVED AND EVALUATION: AN X-RAY OF AN UNDATED AP OF A CEMENTED STEM ENDOPROSTHESIS, THE SIDE OF WHICH IS NOT MARKED, IS PROVIDED. THERE IS A TRANSVERSE FRACTURE OF THE CEMENT NOTED AT THE JUNCTION OF THE MIDDLE AND DISTAL THIRD OF THE COLLARED STEM AND THE HIP IS REDUCED. NO CLINICAL FOLLOW-UP BETWEEN (B)(6) 2010 AND (B)(6) 2013 IS AVAILABLE. THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS AND NO SERIAL X-RAYS OR POST-OPERATIVE REVISION X-RAYS AVAILABLE. NO DETERMINATION CAN BE MADE FOR THE APPARENT FAILURE OF CEMENT FIXATION OF THE STEM IN THIS YOUNG PATIENT WITH SUSPECTED METASTATIC TUMOR DISEASE. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED AND INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS DEVICE RETURN, POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REMOVAL OF LOOSE FEMORAL RELIANCE STEM AND UNITRAX HEAD AND CONVERTING TO A TOTAL HIP.

    Description of Event or Problem · 1

    REMOVAL OF LOOSE FEMORAL RELIANCE STEM AND UNITRAX HEAD AND CONVERTING TO A TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76848 RELIANCE CM CEMENTED HIP #2 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 29317304

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R