BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SCREW,6.5MM DIA,15MM LG

    MDR report key: 2230359 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-16773
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 21, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K951000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE BY DEPUY INTERNATIONAL WAS NOT ABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE OF THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS BY DEPUY INTERNATIONAL FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. CMM MEASUREMENT FINDS LITTLE FORM ERROR SEEN IN THE MEASUREMENTS WHICH SUGGESTS THAT LITTLE WEAR OCCURRED IN VIVO. A REDLUX SCAN FOUND NO ANOMALIES OF THE MATERIAL WEAR. 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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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 REVISED FOR PAIN AND LOOSENING.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO PAIN AND PSEUDOTUMOR IN THE HIP JOINT. ON (B)(6) 2008, THA WAS DONE FOR OA WITH MOM. ABOUT A YEAR AGO, PAIN AND FIXED FLEXION OCCURRED. SLIGHT INFLAMMATION REACTION WAS ALSO NOTED. A FEW OF MONTHS AGO, EXTENSION BECAME POSSIBLE SUDDENLY. AT THE SAME TIME, ABNORMAL NOISE OCCURRED FROM THE HIP. ON (B)(6) 2011, REVISION SURGERY WAS PERFORMED. DURING THE SURGERY, JOINT CAPSULE AND SURROUNDING TISSUE CHANGED THICKENED OR NECROTIZING. BLACK FOREIGN MATTER LIKE METALLIC POWDER WAS FOUND ATTACHED CIRCUMFERENTIALLY IN THE HEAD AND NECK JUNCTION. ALSO THE TISSUE AROUND THE NECK OF THE STEM SEEMED METALLOSIS. THE SHELL DID NOT ADHERE TO THE ACETABULUM AND BONE INGROWTH WAS NOT NOTED IN THE SURFACE OF THE SHELL. THE CUP, HEAD AND INSERT WERE REPLACED AND SURROUNDING TISSUE WAS REMOVED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM*SCREW,6.5MM DIA,15MM LG HIP LPH DEPUY WARSAW 4376070B

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention