BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAND NAME PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #7

    MDR report key: 18245792 · Received December 1, 2023

    Report

    Report Number
    3008021110-2023-00138
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    September 27, 2023
    Report Date
    August 9, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    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. 2209579, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 35 PIECES 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.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT NUMBER. 2209579, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE (B)(4) PIECES MANUFACTURED WITH THAT LOT NUMBER. ACCORDING TO OUR DATA (B)(4) PIECES OUT OF (B)(4) PIECES MANUFACTURED WITH THE INVOLVED LOT NUMBER HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT REPORTED ON THE INVOLVED LOT NUMBER. THE EXPLANTS WERE RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION. DURING A VISUAL INSPECTION OF THE DEVICES NO RELEVANT FINDINGS FOR THIS INVESTIGATION WERE DETECTED. THE PROVIDED X-RAYS AND AVAILABLE INFORMATION WERE SENT TO A MEDICAL CONSULTANT FOR EVALUATION, AND HE CONCLUDED THAT "THIS CASE IS VERY SUSPICIOUS FOR A LOW-GRADE INFECTION AFTER PRIMARY IMPLANTATION. UNFORTUNATELY, THERE IS NO ADDITIONAL INFORMATION FROM THE SURGEON, IF THE LOW-GRADE INFECTION (PJI) WAS CORRECTLY DIAGNOSED AND/OR EXCLUDED[?]AND WE DO NOT KNOW ANYTHING ABOUT PATIENTS HISTORY[?]LOOKING AT THE X-RAYS, THE CHANGES ON THE TIBIAL PLATE AREA LOOK LIKE LOW-GRADE INFECTION, ESPECIALLY ON THE LATERAL X-RAY, WHERE THERE IS A DIFFUSE LOOSENING UNDER TIBIAL COMPONENT, WITH THE TIBIA ALREADY STARTING TO SLIGHTLY TILT ANTERIORLY.THE COMPONENT SIZES OF THE PRIMARY TKA SEEM FINE ON THE X-RAY FROM 13.7.2023. ON THE AP VIEW THE FEMORAL COMPONENT MIGHT BE 1 SIZE BIGGER, BUT ON LATERAL X-RAY FEMUR SIZE 6 LOOKS OK. THE FLEXION POSITION OF THE FEMORAL COMPONENT IS FINE AND ALSO THE ROTATION OF BOTH FEMORAL AND TIBIAL COMPONENTS ARE OK - THERE IS NO MALROTATION. THE TIBIAL COMPONENT SIZE IS PERFECT, TIBIAL SLOPE IS FINE AND ALSO TIBIAL ROTATION LOOKS WITHIN NORMAL RANGE. UNFORTUNATELY, I DO NOT HAVE PREOPERATIVE AND EARLY POSTOPERATIVE X-RAYS AFTER PRIMARY TKA BEFORE THE TIBIAL LOOSENING BEGAN. FROM THE IMAGES YOU HAVE SENT THE ORIENTATION OF THE FEMORAL AND TIBIAL COMPONENT AFTER PRIMARY TKA LOOK FINE. THE BONE QUALITY OF THE LADY IS NOT GOOD. THIS IS A CASE OF AN 80-YEARS OLD LADY, NOT VERY ACTIVE, MOSTLY SEDENTARY. THE BONE IS OSTEOPOROTIC AND I'M SURE IT WAS VERY SOFT INTRAOPERATIVELY. IN SUCH SOFT BONE CONDITION, I ALWAYS RECOMMEND PUTTING AN EXTRA 20MM STEM TO THE TIBIAL COMPONENT TO MINIMIZE THE POTENTIAL OF TIBIAL LOOSENING. THE LADY IS ALSO QUITE HEAVY. ON THE X-RAY YOU CAN SEE A LOT OF CEMENT FILLING (OF THE BONE DEFECT) ON THE MEDIAL SIDE UNDER TIBIAL COMPONENT, WHICH IS CONFIRMATIVE THAT THE BONE STOCK WAS SOFT INDEED, SO THERE IS A REAL POSSIBILITY THAT THE ASEPTIC MECHANICAL LOOSENING OCCURRED DUE TO THE SOFT BONE. SOFT BONE CEMENTATION TECHNIQUE IS ALSO VERY IMPORTANT, I DON'T KNOW HOW IT WAS DONE IN THIS CASE. IF THE PATIENT HAD A TRAUMA TO THE KNEE - LIKE FALLING TO THE GROUND - THE EARLY ASEPTIC LOOSENING IN SOFT BONE CONDITION COULD OCCUR. CONSIDERING ALL THE INFORMATION, I THINK LOW-GRADE INFECTION IS THE CAUSE OF THIS EARLY TIBIAL COMPONENT LOOSENING. THE TIBIAL SIZE IS NOT TOO SMALL, AND THE PATIENT HAS ONLY SEDENTARY ACTIVITY LEVEL, SO THEREFORE I WOULD RULE OUT ASEPTIC MECHANICAL LOOSENING." CONSIDERING THE ABSENCE OF PRE-EXISTING ANOMALIES DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS, AS WELL AS THE X-RAYS ASSESSMENT PERFORMED BY THE MEDICAL EXPERT, WE CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. X-RAYS ANALYSIS HIGHLIGHTED A POSSIBLE LOOSENING DUE TO PATIENT CONDITION-SOFT BONE AND/OR LOW-GRADE INFECTION. PMS DATA: ACCORDING TO PMS DATA REVISION RATE OF TIBIAL PLATE (FAMILY CODE: 6522.15.0XX) DUE TO LOOSENING WW IS NEARLY (B)(4). 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.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF PHYSICA SYSTEM PS, PERFORMED ON (B)(6) 2023, DUE TO LOOSENING PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE: 6522.15.070, LOT NR. 2209579 - STERILIZATION NR. 2200162). PATIENT IS A FEMALE, 80 YEARS OLD. ACCORDING TO THE RECEIVED INFORMATION THE FOLLOWING IMPLANTS GOT EXPLANTED: PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE: 6522.15.070, LOT NR. 2209579 - STERILIZATION NR. 2200162) PHYSICA PS FEMUR COMP. LEFT #6 (PRODUCT CODE: 6515.09.560, LOT NR. 22AS0C0 - STERILIZATION NR. 2200184) PHYSICA PS TIBIAL LINER #7 (PRODUCT CODE: 6535.50.711, LOT NR. 19AT0BC - STERILIZATION NR. 1900189) EVENT HAPPENED IN GERMANY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF PHYSICA SYSTEM PS, PERFORMED ON (B)(6) 2023, DUE TO LOOSENING PHYSICA FIXED TIBIAL. PLATE #7 (PRODUCT CODE: 6522.15.070, LOT NR. 2209579 - STERILIZATION NR. (B)(4)). PATIENT IS A FEMALE, 80 YEARS OLD. ACCORDING TO THE RECEIVED INFORMATION THE FOLLOWING IMPLANTS GOT EXPLANTED: PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE: 6522.15.070, LOT NR. 2209579 - STERILIZATION NR. (B)(4)). PHYSICA PS FEMUR COMP. LEFT #6 (PRODUCT CODE: 6515.09.560, LOT NR. 22AS0C0 - STERILIZATION NR. (B)(4)). PHYSICA PS TIBIAL LINER #7 (PRODUCT CODE: 6535.50.711, LOT NR. 19AT0BC - STERILIZATION NR. (B)(4)). EVENT HAPPENED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605973 BRAND NAME PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #7 TIBIAL PLATE #7 JWH LIMACORPORATE S.P.A. 6522.15.070 2209579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention