BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML SM STATURE 13.5MM

    MDR report key: 3981517 · Received August 5, 2014

    Report

    Report Number
    1818910-2014-25064
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    October 17, 2005
    Report Date
    August 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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..

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DISLOCATION. PATIENT SUFFERED FROM A DISLOCATION ON (B)(6) 2005.

    Description of Event or Problem · 1

    PFS ALLEGES POST TRAUMATIC STRESS DISORDER, DEPRESSION, ANXIETY, INSOMNIA,SPASM, CRAMPS, SWELLING, MUSCLE STRAIN, LIMPING, CONSTIPATION, FEAR, PANIC ATTACK AND IMPLANT DISLOCATION. THERE WAS NO REVISION NOTE PROVIDED. STICKER SHEET SHOWS THAT THE CUP WAS ALSO REVISED, HOWEVER THERE WERE NO REASONS WHY IT WAS REVISED. PFS ALSO REPORTED THAT ON (B)(6) 2005 A SURGERY WAS PERFORMED DUE TO AN ABSCESS OCCURRED IN AN INCISION RESULTED LAST REVISION. HOWEVER, THERE WAS NO OPERATIVE NOTE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457111 AML SM STATURE 13.5MM HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US ZB8KX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention