BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC SIGMA CRVD INSERT SZ3 8MM

    MDR report key: 8564515 · Received April 30, 2019

    Report

    Report Number
    1818910-2019-91967
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    February 26, 2019
    Report Date
    April 9, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    SUBJECT ID: (B)(4). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY - POLYWEAR - ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2005. DOE: (B)(6) 2019. (LEFT KNEE). NOT CONSIDERED RESOLVED; WILL FOLLOW-UP WITH SERIAL X-RAYS. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 864181 LOT: 1841345, COMPONENT TYPE: TIBIAL, DESCRIPTION: PFC TIBIAL CEMENTED 71MM X 47MM. CATALOG ID: 960003 LOT: 084003BC, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET CEMENTED LT SZ 3. CATALOG ID: 960102 LOT: 1846320, COMPONENT TYPE: PATELLAR, DESCRIPTION: OVAL DOME PATELLA 3 PEG SZ 38. CATALOG ID: 960350 LOT: 1843002, COMPONENT TYPE: INSERT, DESCRIPTION: SIGMA TIBIAL INSERT C/RET CVD 8MM SZ 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357764 PFC SIGMA CRVD INSERT SZ3 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 1843002

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR