BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 3180772 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19419
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 6, 2014
    Manufacturer
    DEPUY (IRELAND) - 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN. UPDATE: (B)(6) 2013 - REVISION OPERATIVE REPORT RECEIVED STATING THERE WAS CLOUDY, BROWN JOINT FLUID AND FRETTING BETWEEN THE HEAD BALL AND STEM. FEMORAL STEM, FEMORAL STEM SLEEVE, AND ASR SLEEVE HAVE BEEN ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES PHYSICAL INJURIES, ELEVATED METAL ION LEVELS AND DISFIGUREMENT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014. COMMENT: THERE IS A SIDE DISCREPANCY. THE DER AND MEDICAL RECORDS STATE THE LEFT SIDE, WHILE LITIGATION STATES THE RIGHT FOR THIS REVISION DATE. THE PATIENT IS BILATERAL. FOR ACCURACY, THE SIDE AND DOR FROM THE DER WILL REMAIN. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280936 SROM STM STD 36+12L 13X18 FEMORAL STEM LPH DEPUY (IRELAND) - 9616671 2442240

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR