BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 4093357 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28205
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    February 2, 2011
    Report Date
    March 28, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK963309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

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

    Additional Manufacturer Narrative · 1

    (B)(4).NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THE PATIENT WAS REVISED ON (B)(6) 2011 FOR INFECTION ACCORDING TO THE POST OPERATIVE NOTE (NO REVISION NOTE PROVIDED, ONLY STICKER SHEET). THE HEAD AND LINER WERE REVISED. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2011 FOR CHRONIC INFECTION AND PROSTALAC WAS PLACED. THE HEAD AND LINER PLACED ON (B)(6) 2011 ARE NOT BEING REPORTED AS THERE WAS AN INFECTION AT THAT TIME. THE STEM REMOVED HAS ALREADY BEEN REPORTED ON (B)(4). THIS COMPLAINT IS LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571226 APEX HOLE ELIM POSITIVE STOP HIP OTHER IMPLANT: HOLE LPH 1818910 DEPUY ORTHOPAEDICS, INC. D10070842

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention