BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STEM 75X20MM FLUTED

    MDR report key: 3833870 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-18802
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS 1219655
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THIS MEDWATCH WAS SUBMITTED ON TIME ON (B)(4) 2014. DUE TO OUTAGES ON THE FDA'S RECEIVING SIDE, WE ARE RESUBMITTING THIS MEDWATCH AT THE FDA'S REQUEST.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED YET IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. A CPD REVIEW OF PROVIDED X-RAYS COULD CONFIRM A POSSIBLE FRACTURE OF THE STEM OR SLEEVE; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    XRAYS SHOWED THAT THE THREADED ATTACHMENT ON THE STEM EXTENSION HAD FRACTURED ON THE FEMORAL SIDE. DOCTOR AND PATIENT ARE CURRENTLY EXPLORING OPTIONS, BUT NO DECISION HAS BEEN MADE AS TO FURTHER ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310689 UNIVERSAL STEM 75X20MM FLUTED KNEE STEM NJL DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS 1219655 228795

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention