BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE ZIR BALL 28 +8.5

    MDR report key: 4092271 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28162
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK952088
    Removal / Correction Number
    Z-0235/Z0238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL PIECES FROM THE REPORTED LOTS HAVE BEEN DELIVERED, AND, AS NO ADDITIONAL REPORTS HAVE BEEN RECEIVED, CAN BE REASONABLY ASSUMED IMPLANTED WITHOUT ISSUE. THE REPORT STATES POLYWEAR AND PAIN AFTER MORE THAN 16 YEARS IMPLANTATION. THE PATIENT IS A REPORTED (B)(6) YEAR OLD MALE WITH A CALCULATED (B)(6). THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. 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. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL PIECES FROM THE REPORTED LOTS HAVE BEEN DELIVERED, AND, AS NO ADDITIONAL REPORTS HAVE BEEN RECEIVED, CAN BE REASONABLY ASSUMED IMPLANTED WITHOUT ISSUE. THE REPORT STATES POLYWEAR AND PAIN AFTER MORE THAN 16 YEARS IMPLANTATION. THE PATIENT IS A REPORTED (B)(6) YEAR OLD MALE WITH A CALCULATED (B)(6). THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF POLY WEAR AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571533 ARTICUL/EZE ZIR BALL 28 +8.5 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 RX2J21033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention