BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #9

    MDR report key: 18208228 · Received November 27, 2023

    Report

    Report Number
    3008021110-2023-00135
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    September 18, 2023
    Report Date
    August 9, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    UDI-DI
    08033390092715
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT NUMBER. 2102430, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THAT LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 18 OUT OF 23 PIECES MANUFACTURED WITH LOT NR. 2102430 - STER NR. 2100098, HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THE INVOLVED LOT NUMBER. THE EXPLANTS WERE NOT AVAILABLE TO RETURN TO LIMACORPORATE FOR FURTHER INVESTIGATION. THE X-RAYS PROVIDED BY THE COMPLAINT SOURCE AND THE AVAILABLE INFORMATION WERE EVALUATED BY A MEDICAL CONSULTANT, FOLLOWING HIS COMMENT: "IN THIS CASE THE TIBIAL PLATE LOOSENING OCCURRED LESS THAN 2 YEARS AFTER PRIMARY IMPLANTATION, SO LOW-GRADE INFECTION (PJI) COULD BE THE CAUSE OF TIBIAL LOOSENING.I HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION FROM THE SURGEON IF THE INFECTION WAS RULED OUT.. IF TISSUE SAMPLES WERE TAKEN AT REVISION SURGERY FOR MICROBIOLOGY AND HISTOLOGY TO CONFIRM/EXCLUDE INFECTION AS THE CAUSE OF TIBIAL LOOSENING..FURTHERMORE, I LACK VERY IMPORTANT INFORMATION ABOUT THE PATIENT'S HISTORY..LOOKING AT THE X-RAYS, THE CHANGES ON THE TIBIAL PLATE AREA DO NOT LOOK LIKE LOW-GRADE INFECTION BUT MORE LIKE ASEPTIC MECHANICAL LOOSENING. THERE IS JUST SOME LOOSENING UNDER THE TIBIAL COMPONENT, THE KEEL AREA OF THE TIBIA IS STILL OK AND NO TILTING IS (YET) HAPPENING. THE COMPONENT SIZES OF THE PRIMARY TKA ARE FINE. THE BONE QUALITY IS ALSO GOOD, NOT SOFT, SO THE BONE QUALITY IS NOT A REASON FOR THE MECHANICAL TIBIAL FAILURE. FROM THE IMAGES YOU HAVE SENT THE SIZE OF FEMUR AND TIBIA IS OK. TIBIAL SLOPE IS OK, THERE IS NO FEMORAL NOTCHING. THERE IS QUITE A LOT OF CEMENT MANTLE UNDER LATERAL PART OF TIBIAL PLATE AND LATERAL DISTAL FEMORAL CONDYLE, SO MAYBE THERE WERE SOME MINOR PROBLEMS WITH THE BONE CUTS WHICH WERE SAVED BY CEMENT. THERE AN EXTRA SCREW IN THE FEMUR. THIS MIGHT BE FROM THE PREVIOUS OPERATIONS CONSIDERING ALL THE FACTS I HAVE THIS IS A CASE OF ASEPTIC MECHANICAL LOOSENING. THERE MIGHT BE TROUBLES AT CEMENTATION OR WITH BONE CUTS, PLUS ACTIVE YOUNG PATIENT, WHICH ALL TOGETHER IN THE END LEAD TO TIBIAL PLATE LOOSENING LESS THAN 2 YEARS AFTER PRIMARY IMPLANTATION." BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE EVENT. CONSIDERING THE ABSENCE OF PRE-EXISTING ANOMALIES DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF LOT NR. 2102430 - STER NR. 2100098, AS WELL AS THE X-RAYS ASSESSMENT PERFORMED BY THE MEDICAL EXPERT WE CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO PMS DATA REVISION RATE OF TIBIAL PLATE (PRODUCT CODE: 6522.15.0XX) DUE TO LOOSENING WW IS NEARLY 0,015%. CONSIDERING THE PMS DATA NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR REPORT.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT NUMBER. 2102430, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THAT LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THE INVOLVED LOT NUMBER. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF PHYSICA SYSTEM PS, PERFORMED ON (B)(6) 2023, DUE TO LOOSENING OF PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098). PATIENT IS A MALE, 38 YEARS OLD, ACCORDING TO THE RECEIVED INFORMATION THE FOLLOWING IMPLANTS GOT EXPLANTED: PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098). PHYSICA PS FEMUR COMP. LEFT #9 (PRODUCT CODE 6515.09.590, LOT NR. 20AS0EK - STERILIZATION NR. 2000245). PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE 6535.50.910, LOT NR. 20AT4BS - STERILIZATION NR. 2100132) EVENT HAPPENED IN GERMANY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF PHYSICA SYSTEM PS, PERFORMED ON 18 SEPTEMBER 2023, DUE TO LOOSENING OF PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098). PATIENT IS A MALE, 38 YEARS OLD, ACCORDING TO THE RECEIVED INFORMATION THE FOLLOWING IMPLANTS GOT EXPLANTED: PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098) PHYSICA PS FEMUR COMP. LEFT #9 (PRODUCT CODE 6515.09.590, LOT NR. 20AS0EK - STERILIZATION NR. 2000245) PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE 6535.50.910, LOT NR. 20AT4BS - STERILIZATION NR. 2100132) EVENT HAPPENED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259543 PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #9 TIBIAL PLATE #9, JWH LIMACORPORATE S.P.A. 6522.15.090 2102430 08033390092715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention