BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ2

    MDR report key: 3731993 · Received April 7, 2014

    Report

    Report Number
    1818910-2014-16170
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2170369 AND 1981227 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE FOR THE FEMORAL COMPONENT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    REASON FOR REVISION: LOOSENING AND LYSIS AND PATIENT HAD RHEUMATOID ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206813 PFC KEEL TIB TRAY CEM SZ2 KNEE TIBIAL TRAY JWH DEPUY IRELAND ¿ REG. # 9616671 2170369

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention