BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18F-SML

    MDR report key: 3163484 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18637
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 6, 2011
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY (IRELAND) - 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    UPDATED: EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR 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.

    Description of Event or Problem · 1

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. DOI: (B)(6) 2008 - DOR: (B)(6) 2011. UPDATE: (B)(6) 2011 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT PATIENT HAS EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: (B)(6) 2012, PATIENT FACT SHEET (PFS) FORM AND IMPLANT STICKERS RECEIVED WHICH IDENTIFIED THE PATIENT'S DOB. COMPLAINT FILE UPDATED AND PFS ATTACHED TO FILE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOB: (B)(6) 1949. **UPDATE** 05/15/2013- PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION METAL STAINED FLUID WITH THE BURSAL REGION AND THE STEM AND SLEEVE WERE BOTH FOUND LOOSE. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT AND THE COMPLAINT RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263798 S-ROM*SLEEVE PRX ZTT, 18F-SML SLEEVE LPH DEPUY (IRELAND) - 9616671 2150227

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention