BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA FIXED TIBIAL PLATE #2

    MDR report key: 16501978 · Received March 8, 2023

    Report

    Report Number
    3008021110-2023-00021
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 16, 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 THE INVOLVED LOT #2101778, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS WITH THAT LOT. THEREFORE, WE CAN STATE THAT THEY WERE MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS. ACCORDING TO OUR RECORDS, AT LEAST 21 OUT 24 OF PHYSICA TIBIAL PLATES WITH LOT NR. 2101778 - STER. 2100098 HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE FOLLOWING X-RAYS (DATED AFTER THE PRIMARY SURGERY DATED 17TH MARCH 2022) WERE RECEIVED AND ANALYZED BY A MEDICAL EXPERT, TOGETHER WITH THE AVAILABLE OPERATIVE NOTES PROVIDED BY THE COMPLAINT SOURCE: - MARCH 22ND, 2022. - JUNE 7TH, 2022. - SEPTEMBER 20TH, 2022. - NOVEMBER 22ND, 2022. WITH REFERENCE TO THE PRIMARY SURGERY, THE MEDICAL EXPERT CONCLUDED THE FOLLOWING: "PRIMARY TKA PERFORMED ON 17TH MARCH 2022 WITH THE DIAGNOSIS OF THE PANGONARTHRISIS OF THE RIGHT KNEE. ACCORDING TO THE OPERATIVE TECHNIQUE WAS MEASURED RESECTION WITH THE TOURNIQUET AND DISTAL FEMUR VALGUS ANGLE USED WAS 6°. THERE WAS CORRECT POSITION OF THE FEMORAL COMPONENT WITH UNDER-SIZING, BUT EXTENSIVE DORSAL SLOPE AND INCREASED TIBO-TALAR TILT ANGLE. AFTER 3, 6 AND 8 MONTHS AFTER THE SURGERY THERE WERE PROGRESSIVE SIGNS OF ASEPTIC LOOSENING ON THE X-RAYS. THERE IS CAVITATION IN THE LATERAL TIBIAL EPICONDYLE ON THE X-RAY TAKEN 8 MONTHS AFTER THE SURGERY." WITH REFERENCE TO THE REVISION SURGERY, THE MEDICAL EXPERT CONCLUDED THE FOLLOWING: "TOTAL KNEE REVISION SURGERY DUE TO FACTS OF ASEPTIC LOOSENING OF BOTH COMPONENTS. ACCORDING TO THE REPORT THERE WAS SEPARATION OF THE BONE-CEMENT/BONE, AS WELL AS BONE-CEMENT/IMPLANT PRESENTED. NO MACROSCOPIC SINGS OF SEPTIC LOOSENING. THE PROGRESSIVE ASEPTIC LOOSENING COULD BE EXPLAINED WITH THE INCREASED MEDIAL INCLINATION AND DORSAL SLOPE OF THE TIBIAL COMPONENT. THE CEMENTING TECHNIQUE IS IMPORTANT FACTOR AS WELL-THERE IS NO INFORMATION ABOUT THIS. THE LOOSENING OF THE FEMORAL COMPONENT IS SUPPORTING THE THEORY OF THE IMPROPER CEMENTING TECHNIQUE." THE EXPLANTED COMPONENTS WERE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS AND NO ANOMALIES WERE DETECTED DURING A VISUAL INSPECTIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED LOOSENING CANNOT BE DETERMINED WITH CERTAINTY. HOWEVER, CONSIDERING THAT: - THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT NUMBER. - THE VISUAL INSPECTION DID NOT HIGHLIGHT ANY ANOMALIES. - AND ACCORDING TO OUR MEDICAL EXPERT "THE PROGRESSIVE ASEPTIC LOOSENING COULD BE EXPLAINED WITH THE INCREASED MEDIAL INCLINATION AND DORSAL SLOPE OF THE TIBIAL COMPONENT. THE CEMENTING TECHNIQUE IS IMPORTANT FACTOR AS WELL-THERE IS NO INFORMATION ABOUT THIS. THE LOOSENING OF THE FEMORAL COMPONENT IS SUPPORTING THE THEORY OF THE IMPROPER CEMENTING TECHNIQUE." WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF PHYSICA FIXED TIBIAL PLATE (FAMILY CODE: 6522.15.XXX) DUE TO LOOSENING IS 0,02%. 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. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF A PHYSICA PS IMPLANT DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #2 (PRODUCT CODE 6522.15.020, LOT #2101778 - STER. 2100098). THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: PHYSICA FIXED TIBIAL PLATE #2 (PRODUCT CODE 6522.15.020, LOT #2101778 - STER. 2100098); PHYSICA PS FEMUR COMP.RIGHT #2 (PRODUCT CODE 6515.09.120, LOT #17AS0BS - STER. 1700347); PHYSICA PS TIBIAL LINER #2 (PRODUCT CODE 6535.50.210, LOT #20BC03C - STER. 2000293); PHYSICA PATELLA PROSTHESIS D.26MM (PRODUCT CODE 6595.50.026, LOT #19AT0BL - STER. 1900184). THE DATE OF THE REVISION SURGERY WAS NOT DETAILED OUT. ACCORDING TO THE RECEIVED INFORMATION, PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. PATIENT IS A FEMALE, 71 YEARS OLD. IT WAS REPORTED SHE'S 1.68M HEIGH AND SHE WEIGHTED 64KGS AT THE TIME OF PREVIOUS SURGERY. SHE'S ACTIVE BUT SUFFERS OF OSTEOPOROSIS AND ASTHMA. EVENT HAPPENED IN GERMANY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY OF A PHYSICA PS IMPLANT DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #2 (PRODUCT CODE 6522.15.020, LOT #2101778 - STER. 2100098). THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: · PHYSICA FIXED TIBIAL PLATE #2 (PRODUCT CODE 6522.15.020, LOT #2101778 - STER. 2100098) · PHYSICA PS FEMUR COMP.RIGHT #2 (PRODUCT CODE 6515.09.120, LOT #17AS0BS - STER. 1700347) · PHYSICA PS TIBIAL LINER #2 (PRODUCT CODE 6535.50.210, LOT #20BC03C - STER. 2000293) · PHYSICA PATELLA PROSTHESIS D.26MM (PRODUCT CODE 6595.50.026, LOT #19AT0BL - STER. 1900184). THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THE DIAGNOSIS WAS MOST PRONOUNCED RETROPATELLAR PANGONARTHROSIS IN THE AREA OF THE RIGHT KNEE JOINT. PATIENT IS A FEMALE, 71 YEARS OLD. IT WAS REPORTED SHE'S 1.68M HEIGH AND SHE WEIGHTED 64KG AT THE TIME OF PREVIOUS SURGERY. SHE'S ACTIVE BUT SUFFERS OF OSTEOPOROSIS AND ASTHMA. EVENT OCCURRED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736310 PHYSICA FIXED TIBIAL PLATE #2 TIBIAL PLATE #2, JWH LIMACORPORATE S.P.A. 6522.15.020 2101778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other