BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 50OD X 28ID

    MDR report key: 2011325 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03350
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT CONTACTED (B)(4) TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. (RIGHT SIDE). **UPDATE** STICKER SHEET RECEIVED. PRODUCT AND LOT NUMBERS WERE IDENTIFIED. THE REASON FOR REVISION IS STILL UNKNOWN. DOI: (B)(6) 2007 - DOR: (B)(6) 2011. **UPDATE** PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS, PAIN AND LOOSENING. THE SALES REP WAS AWARE OF THIS INFORMATION AT THE TIME OF REVISION; HOWEVER, IT WAS REPORTED TO DEPUY LATE AND IS NOW BEING UPDATED TO THE COMPLAINT. AN ADDITIONAL MDR WAS REPORTED AS THE REASON FOR REVISION WAS IDENTIFIED. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 TO ADDRESS POLY WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 50OD X 28ID 87HRY, HSX, JDB, JDI, JWH, KWA, AND KWT LPH DEPUY ORTHOPAEDICS, INC. NA 2195144

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention