BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER NEUT 54OD X 28ID

    MDR report key: 2175521 · Received July 21, 2011

    Report

    Report Number
    1818910-2011-12165
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS OR PATIENT X-RAYS WERE AVAILABLE FOR INVESTIGATION AND THAT: THE IMPLANT WEAR OCCURRED DUE TO AGE DETERIORATION. IT WAS NOTED THAT THESE PRODUCTS HAD BEEN IMPLANTED FOR OVER 15 YEARS. COMPLAINT REVIEW IDENTIFIED THAT IN THE ABSENCE OF PRODUCT AND FURTHER INFORMATION, AN INVESTIGATION COULD NOT BE COMPLETED. REVIEW OF PRODUCT LOT FCW-11 MANUFACTURING RECORDS IDENTIFIED THAT PRODUCT LOT FCW-11 ACTUALLY REFERENCES A 1200 SERIES DURALOC SHELL PRODUCT 54MM O/D AND NOT A HYLAMER LINER PRODUCT AS REFERENCED AS ON ETQ. REVIEW OF HEAD PRODUCT LOT CCD-13 MANUFACTURING RECORDS IDENTIFIED NO ANOMALIES. THE ROOT CAUSE IS INDETERMINABLE. THERE ARE MANY CONTRIBUTORY FACTORS THAT CAN AFFECT WEAR RATES SUCH AS: - PATIENT ACTIVITY, SURGICAL IMPLANTATION TECHNIQUE, PATIENT SUITABILITY, SHELF LIFE AT TIME OF IMPLANTATION, SUITABILITY OF MATING COMPONENTS, METHOD OF STERILIZATION ETC. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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

    THE PT WAS REVISED DUE TO IMPLANT WEAR. OSTEOLYSIS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER NEUT 54OD X 28ID 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA FCW11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention