BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA PS FEMUR COMP.RIGHT #4

    MDR report key: 18442893 · Received January 4, 2024

    Report

    Report Number
    3008021110-2023-00146
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    November 22, 2023
    Report Date
    March 8, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    PMA / PMN Number
    K152008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED, THEREFORE WE CAN STATE THE DEVICES HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED (LOT 20AS0AB - STER. 2000181; LOT 20BC04X - STER. 2100143; LOT 2102509 - STER. 2100105), THEREFORE WE CAN STATE THESE DEVICES HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EVEN THOUGH REQUESTED THE FOLLOWING DETAILS WERE NOT PROVIDED TO LIMACORPORATE: - X-RAYS. - PATIENT CLINICAL DATA. - PATHOGEN RESPONSIBLE FOR THE INFECTION. - SPECIFIC DATE WHEN THE DEVICES WERE IMPLANTED. THEREFORE, CONSIDERING THAT: 1) THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED (LOT 20AS0AB - STER. 2000181; LOT 20BC04X - STER. 2100143; LOT 2102509 - STER. 2100105) IN THE EVENT HAVE BEEN CHECKED WITHOUT FINDING ANY PRE-EXISTING ANOMALY. 2) X-RAYS AND ADDITIONAL INFORMATION WERE NOT AVAILABLE TO BE ANALYZED WE ARE NOT ABLE TO INVESTIGATE FURTHER THE EVENT, HOWEVER BASED ON THE FEW AVAILABLE INFORMATION RECEIVED AND ANALYSIS PERFORMED WE CAN CLASSIFY THE EVENT AS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE DUE TO INFECTION OF PHYSICA PS FEMUR COMP. (FAMILY CODE: 6515.09.XXX), IS ABOUT 0,01%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    RIGHT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE PREVIOUS SURGERY TOOK PLACE IN 2021 (EXACT DATE NOT KNOWN). DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE REMOVED: PHYSICA PS FEMUR COMP.RIGHT #4, CODE 651509140, LOT 20AS0AB, STER. 2000181; PHYSICA PS TIBIAL LINER #3, CODE 653550311, LOT 20BC04X, STER. 2100143; PHYSICA TIBIAL STEM L.20MM, CODE 659015020, LOT 2102509, STER. 2100105; PHYSICA FIXED TIBIAL PLATE #3, CODE 6522.15.030, LOT UNKNOWN. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    RIGHT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE PREVIOUS SURGERY TOOK PLACE IN 2021 (EXACT DATE NOT KNOWN). DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE REMOVED: - PHYSICA PS FEMUR COMP.RIGHT #4, CODE 651509140, LOT 20AS0AB, STER. 2000181 - SOLD IN US. - PHYSICA PS TIBIAL LINER #3, CODE 653550311, LOT 20BC04X, STER. 2100143 - SOLD IN US. - PHYSICA TIBIAL STEM L.20MM, CODE 659015020, LOT 2102509, STER. 2100105 - SOLD IN US. - PHYSICA FIXED TIBIAL PLATE #3, CODE 652215030, LOT UNKNOWN. (INFORMATION TAKEN BY THE PICTURES OF EXPLANTED DEVICE PROVIDED BY COMPLAINT SOURCE, LOT NUMBER NOT VISIBLE) - SOLD IN US. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606799 PHYSICA PS FEMUR COMP.RIGHT #4 PS FEMORAL COMPONENT RIGHT #4, JWH LIMACORPORATE S.P.A. 6515.09.140 20AS0AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention