BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG RP AOX STB INS SZ2.5 17.5

    MDR report key: 10297733 · Received July 20, 2020

    Report

    Report Number
    1818910-2020-16254
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 3, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295076476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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.

    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

    PATIENT WAS REVISED DUE TO CONFIRMED INFECTION. PATIENT ORIGINAL SURGERY WAS AT PVH ON (B)(6) 2019 WHEREBY PATIENT UNDERWENT A SIGMA COMPLEX PRIMARY CONSTRUCT WITH A PS SIGMA FEMUR, CEMENTED STEM AND A RP REV SIGMA TIBIA WITH CEMENTED STEM. PATIENT IS CONFIRMED FOR INFECTION TODAY AND ANOTHER POLY EXCHANGE WAS PERFORMED. PATIENT HAS A HISTORY ON POLY EXCHANGE RECENTLY 1 ON (B)(6) 2019 AND ONE ON (B)(6) 2020. TO BE CLEAR, PATIENT HAD THE I&D AND POLY SWAP PERFORMED TODAY (B)(6) 2020. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762581 SIG RP AOX STB INS SZ2.5 17.5 SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 1961-92-124 8661093 10603295076476

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SIG RP AOX STB INS SZ2.5 17.5