BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT POR TAPER SZ8 STD OFF

    MDR report key: 3870784 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20912
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    February 13, 2014
    Report Date
    July 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATION. THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. 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.

    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.

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY. PATIENT HAS BEEN REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. UPDATE: (B)(6) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES DISABILITY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC¿D (B)(6) 2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS ALVAL. UPON REVISION, CLEAR SLIGHTLY BROWN TINGED FLUID, TISSUE NECROSIS, AND TRUNNIONOSIS WITH BLACKENED AREAS ON THE TRUNNION (NO MAJOR DEFECTS) WERE NOTED. THE SLEEVE AND STEM ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347603 SUMMIT POR TAPER SZ8 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 1818910 XX2BP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR