BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR TIB. LINER LEFT #5

    MDR report key: 8018234 · Received October 30, 2018

    Report

    Report Number
    3008021110-2018-00070
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    September 19, 2018
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HRY
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE STERILIZATION CHARTS OF THE FOLLOWING COMPONENTS, IMPLANTED DURING PREVIOUS SURGERY: PHYSICA KR TIB. LINER LEFT #5 CODE 6532.50.516 LOT# 14L0624, STER. 1500224; PHYSICA KR FEMUR COMP. LEFT #4 CODE 6511.09.540 LOT# 17AS01J, STER. 1700063; PHYSICA FIXED TIBIAL PLATE #5 CODE 6522.15.050 LOT# 1800551, STER. 1800062; PHYSICA PATELLA PROSTH. D.29MM CODE 6595.50.029 LOT# 17AT1WT, STER. 1800001. NO ANOMALY WAS FOUND, THUS ALL THESE COMPONENTS HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. DURING THIS SURGERY ONLY THE POLY LINER (CODE 6532.50.516, LOT# 14L0624) WAS REPLACED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2018. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859246 PHYSICA KR TIB. LINER LEFT #5 KR LINER LEFT #5 - H. 16 (HRY JWH) HRY LIMACORPORATE S.P.A. 6532.50.516 14L0624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention