BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM LT SZ 4

    MDR report key: 7125128 · Received December 18, 2017

    Report

    Report Number
    1818910-2017-51859
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LXH
    UDI-DI
    10603295231967
    PMA / PMN Number
    K9434620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOWING IMPLANTS WERE REMOVED BY SURGEON DURING REVISION SURGERY DUE TO POLYETHYLENE WEAR AND TIBIAL AND FEMORAL LOOSENING SIZE 4 TIBIA. 866024 LOT 2063687 SIZE 4 LEFT CR FEMUR 960004 LOT UNREADABLE SIZE 4 8MM PLI INSERT 158104008? LOT 2048223 ORIGINAL SURGERY APPROXIMATELY 11 YEARS AGO. NO REPORT IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904337 PFC*SIGMA C/R NPOR FEM LT SZ 4 KNEE FEMORAL LXH DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN 10603295231967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention