BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +13 BLK

    MDR report key: 5288755 · Received December 11, 2015

    Report

    Report Number
    1818910-2015-37266
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    December 9, 2010
    Report Date
    October 9, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 11/20/15-PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR REPORTABILITY. PFS REPORTED DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, EMOTIONAL DISTRESS, CONSEQUENCES RELATED TO METAL ION EXPOSURE, PAIN, PAINFUL ITCHY RASH, DISLOCATIONS, HIP FRACTURE, CONFINED TO WHEELCHAIR, LOSS OF INDEPENDENCE AND HOMEBOUND. MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED POPPING, INSTABILITY, SEVERAL EPISODES OF SUBLUXATION, AND DEFICIENT ABDUCTORS. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE FEMORAL HEAD AND ONE OTHER AGAINST THE LINER. REVIEW OF THE LINER DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    (B)(6) 2015-PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR REPORTABILITY. PFS REPORTED DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, EMOTIONAL DISTRESS, CONSEQUENCES RELATED TO METAL ION EXPOSURE, PAIN, PAINFUL ITCHY RASH, DISLOCATIONS, HIP FRACTURE, CONFINED TO WHEELCHAIR, LOSS OF INDEPENDENCE AND HOMEBOUND. MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED POPPING, INSTABILITY, SEVERAL EPISODES OF SUBLUXATION, AND DEFICIENT ABDUCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820717 ARTICUL/EZE BALL 32 +13 BLK HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD - 8010379 2514140

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention