BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM AMT SZ2 STD OFFSET

    MDR report key: 3822298 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19161
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    December 1, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    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 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.

    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.(B)(4). 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

    UPDATE REC'D 8/7/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, A SMALL AMOUNT OF FLUID, A GRAYISH DISCOLORATION OF TISSUE AND A FEMORAL NECK FRACTURE WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 08/21/2014.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLETE THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM. DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS RESIDENT OF (B)(6). UPDATE: (B)(6) 2014 DER RECEIVED. ADDITIONAL REASONS FOR REVISION PAIN AND STEM LOOSENING. ADDED PRODUCT PAGES SURGEON - (B)(6). DOR (B)(6) 2014. HOSPITAL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300804 C-STEM AMT SZ2 STD OFFSET HIP FEMORAL STEM/SLEEVE JDI DEPUY IRELAND 9616671 D08110284

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention