BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA FIXED TIBIAL PLATE #8

    MDR report key: 14621345 · Received June 7, 2022

    Report

    Report Number
    3008021110-2022-00045
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 11, 2022
    Report Date
    August 22, 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

    THE STERILIZATION CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY FOUND ON THE 36 PHYSICA FIXED TIBIAL PLATE #8 THAT BELONG TO PRODUCT CODE 6522.15.080, LOT N. 2105609, STER. 2100165. NO PRE-EXISTING ANOMALY FOUND ON THE 53 PHYSICA PS TIBIAL LINER #8 THAT BELONG TO PRODUCT CODE 6535.50.811, LOT N. 19BC023, STER. 2000265. THEREFORE WE CAN STATE THAT THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE STERILIZATION CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY ON THE 36 PHYSICA FIXED TIBIAL PLATE #8 THAT BELONG TO PRODUCT CODE 6522.15.080, LOT N. 2105609, STER. 2100165. NO PRE-EXISTING ANOMALY ON THE 53 PHYSICA PS TIBIAL LINER #8 THAT BELONG TO PRODUCT CODE 6535.50.811, LOT N. 19BC023, STER. 2000265. NO PRE-EXISTING ANOMALY ON THE 56 PHYSICA TIBIAL STEM L. 20 MM PRODUCT CODE 6590.15.020, LOT N. 2105598, STER. 2100174. THEREFORE, WE CAN STATE THAT THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, SPECIFICALLY: CULTIVATION RESULTS; PRE- OPERATIVE X-RAYS AND POST-OPERATIVE X-RAYS OF THE PREVIOUS SURGERY; PRE- OPERATIVE X-RAYS AND POST-OPERATIVE X-RAYS OF THE REVISION SURGERY; CLINICAL DATA OF THE PATIENT. THE COMPLAINT SOURCE SHARED ONLY ONE X-RAY IMAGE TAKEN BEFORE THE REVISION SURGERY, WHICH WAS SENT TO OUR MEDICAL CONSULTANT. UNFORTUNATELY, IT WAS IMPOSSIBLE TO RETRIEVE FURTHER INFORMATION, SO OUR MEDICAL EXPERT COULD NOT PERFORM ANY FURTHER CLINICAL EVALUATION. IN CONCLUSION, BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. WE COULD ONLY CHECK THE STERILIZATION CHARTS OF THE INVOLVED DEVICES, WHICH CONFIRM THE ABSENCE OF ANY PRE-EXISTING ANOMALIES. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF PHYSICA SYSTEM DUE TO INFECTION OF ABOUT 0,01%. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    RIGHT KNEE REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2022. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE INVOLVED COMPONENTS ARE LISTED BELOW: PHYSICA FIXED TIBIAL PLATE #8 PRODUCT CODE 6522.15.080, LOT N. 2105609, STER. 2100165. PHYSICA PS TIBIAL LINER #8 PRODUCT CODE 6535.50.811, LOT N. 19BC023, STER. 2000265. PHYSICA TIBIAL STEM (PRODUCT INFORMATION TO BE CONFIRMED AFTER DOUBLE CHECK WITH THE HOSPITAL). FEMORAL COMPONENT (PRODUCT INFORMATION UNKNOWN). PATELLA (PRODUCT INFORMATION UNKNOWN). THE PATIENT IS (B)(6) YEARS OLD. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    RIGHT KNEE REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2022. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO DEGENERATIVE ARTHROSIS ON THE RIGHT KNEE. THE INVOLVED COMPONENTS ARE LISTED BELOW: PHYSICA FIXED TIBIAL PLATE #8 PRODUCT CODE 6522.15.080, LOT N. 2105609, STER. 2100165 PHYSICA PS TIBIAL LINER #8 PRODUCT CODE 6535.50.811, LOT N. 19BC023, STER. 2000265 PHYSICA TIBIAL STEM L.20 MM PRODUCT CODE 6590.15.020, LOT N. 2105598, STER. 2100174 FEMORAL COMPONENT (PRODUCT INFORMATION UNKNOWN) PATELLA (PRODUCT INFORMATION UNKNOWN) THE PATIENT IS (B)(6). THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216605 PHYSICA FIXED TIBIAL PLATE #8 TIBIAL PLATE #8 HRY LIMACORPORATE S.P.A. 6522.15.080 2105609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention