BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR TIBIAL LINER LEFT #8

    MDR report key: 11806209 · Received May 11, 2021

    Report

    Report Number
    3008021110-2021-00036
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 22, 2021
    Report Date
    January 10, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HRY
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHR OF THE LOT #14L0124, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    DURING A RIGHT KNEE SURGERY PERFORMED ON APRIL 22ND, 2021, THE LEFT COMPONENT PHYSICA KR TIBIAL LINER LEFT #8 (PRODUCT CODE 6532.50.812, LOT# 14L0124 - STER. 1900395) WAS IMPLANTED IN THE RIGHT KNEE. THE INCORRECT SIDE KR LINER WAS INSERTED WITH THE CONTRA LATERAL FEMUR. IT WAS REPORTED THAT BOTH SIDES OF PHYSICA KR LINERS WERE AVAILABLE IN THE OR. PATIENT IS A MALE, 64 YEARS OLD. AS AN UPDATE, WE WERE INFORMED THAT ON JULY,27TH 2021 SURGEON OPTED FOR A REVISION SURGERY WHERE A RIGHT PHYSICA KR TIBIAL LINER #8 - PRODUCT CODE 6531.54.812, LOT# 2021290, STER. 2100076 - WAS CORRECTLY IMPLANTED. EVENT HAPPENED IN THE US.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #14L0124, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING A RIGHT KNEE SURGERY PERFORMED ON (B)(6) 2021, THE LEFT COMPONENT PHYSICA KR TIB. LINER LEFT #8 (PRODUCT CODE 6532.50.812, LOT# 14L0124 - STER. 1900395) WAS IMPLANTED IN THE RIGHT KNEE. THE INCORRECT SIDE KR LINER WAS INSERTED WITH THE CONTRA LATERAL FEMUR. IT WAS REPORTED THAT BOTH SIDES OF PHYSICA KR LINERS WERE AVAILABLE IN THE OPERATING ROOM. PATIENT IS A MALE, (B)(6) YEARS OLD. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701631 PHYSICA KR TIBIAL LINER LEFT #8 KR LINER LEFT #8 - H. 12 HRY LIMACORPORATE S.P.A. 6532.50.812 14L0124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other