BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,38

    MDR report key: 5980907 · Received September 27, 2016

    Report

    Report Number
    1818910-2016-28194
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 31, 2016
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL DER STATES PATIENT WAS REVISED TO ADDRESS LOOSENING. WHAT WAS LOOSE AND THE INTERFACE ARE UNKNOWN AT THIS TIME. DEPUY CEMENT WAS USED. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS EXPERIENCING PAIN. UPON REVISION THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE. ALSO NOTED WAS OSTEOLYSIS IN THE POSTERIOLATERAL FEMUR AND THE POSTEROMEDIAL TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632683 PFC*SIGMA/RD/DOME PAT 3PEG,38 KNEE PATELLAR COMPONENT JWH DEPUY (IRELAND) 9616671 D11061776

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention