BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 3103405 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01605
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    WEIGHT, LOT, STERI LOT, MANUFACTURING DATE, AND EXPIRATION DATE UPDATED. AN EVENT REGARDING LOOSENING, INFECTION AND METALLOSIS INVOLVING A EXETER V40 STEM 35.5MM WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL OF THE RETURNED DEVICE CONCLUDED THAT THERE IS EVIDENCE OF IMPINGEMENT OF THE NECK OF THE EXETER STEM ON BOTH THE TITANIUM SLEEVE AND THE CERAMIC INSERT OF THE TRIDENT CERAMIC INSERT ASSEMBLY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS ANALYSIS. A DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO PREVIOUSLY REPORTED SIMILAR EVENTS FOR THE SAME LOT NUMBER. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS PROCEDURE-RELATED WITH REGARD TO COMPONENT MALPOSITION OF AN UNDETERMINED DEGREE OR TYPE DUE TO LACK OF X-RAY VERIFICATION AND EVEN IF INFECTION WOULD HAVE BEEN PRESENT, UNLIKELY THOUGH, THIS WOULD ALSO BE A PROCEDURE-RELATED COMPLICATION AFTER SURGERY. NO INDICATION FOR PRESENCE OF DEVICE RELATED PROBLEMS AS ALSO SUPPORTED BY THE MAR FINDINGS. THIS CASE IS NOT DEVICE-RELATED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PATIENT HAD A REVISION THA DUE TO STEM LOOSENING AND SUSPECTED OF INFECTION. DURING THE SURGERY, A SURGEON NOTICED THAT THERE WAS METALLOSIS IN THE HIP JOINT. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A CEMENT MOLD TO SAVE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PATIENT HAD A REVISION THA DUE TO STEM LOOSENING AND SUSPECTED OF INFECTION. DURING THE SURGERY, A SURGEON NOTICED THAT THERE WAS METALLOSIS IN THE HIP JOINT. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A CEMENT MOLD TO SAVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203693 EXETER V40 STEM 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G2487758

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O| R