BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2151211 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11709
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. THE CUP POSITION REPORTED OF 62 DEGREES IS MORE VERTICAL THAN RECOMMENDED BY SURGICAL TECHNIQUE. OVERLY VERTICAL CUP POSITION CAN CONTRIBUTE TO INCREASED MATERIAL WEAR. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION INVOLVING ANY OTHER PATIENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS SUBLUXATION AND SUSPECTED INFECTION. ALL CULTURES CAME BACK NEGATIVE, BUT SURGEON DRAINED 50CCS OF A MILKY, MURKY FLUID FROM BOTH INSIDE AND OUTSIDE THE CAPSULE. THE METAL HEAD AND METAL LINER SHOWED SIGNIFICANT SIGNS OF WEAR. THE CUP WAS AT APPROX 62 DEGREES OF INCLINATION AND SOMEWHAT RETROVERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +1.5 87 JDI; 87LPH JDI DEPUY INTERNATIONAL, LTD. NA 2716372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention