BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 12D-LRG

    MDR report key: 3063343 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15476
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT PROBLEM. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF PROVIDED PATIENT X-RAY PHOTOGRAPH FINDS DECREASED RADIOGRAPHIC DENSITY IS NOTED ON RIGHT FEMUR¿S STEM COMPONENT/CORTICAL WALL INTERFACE. PROXIMAL BODY/NECK ON IMPLANT FOR THE RIGHT FEMUR IS ALSO IN CLOSE PROXIMITY TO THE RESECTED NECK REGION ABOVE THE LESSER TROCHANTER. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO STEM LOOSENING.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2013 PRODUCT/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165409 S-ROM*SLEEVE PRX ZTT, 12D-LRG SLEEVE LPH DEPUY ORTHOPAEDICS 1040581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention