BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 11858248 · Received May 20, 2021

    Report

    Report Number
    1818910-2021-10851
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295021643
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    IT WAS REPORTED THAT THE KNEE HAD A 40 DEGREE CONTRACTURE AND WAS TIGHT. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752277 LCS COMPLETE FEM CEM L LG LCS COMPLETE : KNEE FEMORAL NJL DEPUY ORTHOPAEDICS INC US 1294-02-060 9324314 10603295021643

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention LCS COMP RP INSERT LG 10MM| LCS COMPLETE POLY PATELLA LG| MBT CEM KEEL TIB TRAY SZ5