BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ2 STD OFF

    MDR report key: 4792294 · Received May 22, 2015

    Report

    Report Number
    1818910-2015-21511
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO A FALL AND HAD PAIN IN THE PROXIMAL TIBIA. IT WAS NOTED THAT THERE WAS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE WHICH WAS THE CAUSE OF THE PATIENT'S PAIN. MANUFACTURER OF CEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335470 SUMMIT POR TAPER SZ2 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. 563199

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention