BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT

    MDR report key: 16900702 · Received May 10, 2023

    Report

    Report Number
    3008021110-2023-00047
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBH
    UDI-DI
    08033390174299
    PMA / PMN Number
    K201084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (2202412), NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE WAS DETECTED ON THE TIBIAL PLATES RELEASED WITH THE SAME LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    AT THE RECEIPT OF THE DEVICE IT WAS NOTICED THAT THE CODE AND LOT NUMBER OF THE DEVICE (PHYSICA TT FIX. TIBIAL TRAY #5 COMMERCIAL CODE 652114050 - LOT #2202412 - STER. #(B)(4)) REPORTED ON THE INITIAL MDR REPORT WERE NOT CORRECT. THE COMPLAINT SOURCE CONFIRMED THAT THE CORRECT DEVICE CODE AND LOT NUMBER ARE PHYSICA TT FIX. TIBIAL TRAY #6 (CODE: 6521.14.060 - LOT # 2200474 - STER. # (B)(4)), AS INDICATED IN THE CURRENT REPORT. BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (2200474), NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE WAS DETECTED ON THE TIBIAL PLATES RELEASED WITH THE SAME LOT NUMBER. THEREFORE, WE CAN STATE THAT THEY WERE MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS ACCORDING TO OUR DATA, ALL THE 13 PIECES MANUFACTURED WITH LOT # 2200474 - STER. # (B)(4) HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER INVOLVED. THE EXPLANTED DEVICE WAS RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION. FROM A VISUAL INSPECTION OF THE RETURNED EXPLANT, NO RELEVANT OBSERVATIONS COULD BE MADE IN RELATION TO THE DESCRIBED EVENT. X-RAYS IMAGES DATED (B)(6) 2023 (POST-OP AP AND ML X-RAYS), (B)(6) 2023 (POST-OP AFTER 2 MONTHS) AND (B)(6) 2023 (REVISION POST-OP), WERE PROVIDED TO LIMACORPORATE BY THE COMPLAINT SOURCE. THE AVAILABLE INFORMATION AND X-RAYS WERE SHARED WITH A MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HIS COMMENTS ARE REPORTED HEREAFTER: - WITH REFERENCE TO POST-OP AP AND POST-OP ML X-RAYS DATED ON (B)(6) 2023, HE CONCLUDED: "TKA IS PROBABLE PLACED IN NEUTRAL POSITION - (NO INFORMATION ABOUT THE OPERATIVE TECHNIQUE.) THE SIZING OF TIBIAL AND FEMORAL COMPONENT- OVERSIZING OF BOTH COMPONENTS WITH MEDIAL INCLINATION OF LESS THAN 2,0°. FEMORAL COMPONENT IN 5,0° OF FLEXION, NOT FULL BONE CONTACT. PATTELAR COMPONENT IS NOT POSSIBLE VERIFY (RADIOLOGICALLY)." - WITH REFERENCE TO POST-OP X-RAYS DATED ON (B)(6) 2023 AND TIBIAL EXPLANTED PHOTO, HE CONCLUDED: "AFTER TWO MONTHS THE TIBIAL COMPONENT IS SUBSIDED AND TILTED. MEDIAL PROXIMAL TIBIAL ANGLE IS 70°. THE RETIRED FEMALE PATIENT WITH STRONGLY REDUCED ACTIVITY AND SUSPECTED PERIOPERATIVE FRACTURE- (BUMP ON THE X-RAY INITIAL POST-OP AP) THE VERY LIKELY EXPLANATION FOR SUCH A RAPID MIGRATION IS THE PERIPROSTHETIC FRACTURE IN THE POOR BONE QUALITY ON THE MEDIAL TIBIAL EPICONDYLE DUE TO THE MINOR TRAUMA. THIS THEORY IS CONFIRMED ON THE EXPLANT PHOTO -THE RED ARROWS ARE INDICATING FIBROUS TISSUE ON THE MEDIAL SIDE COMPARED WITH THE BONY TISSUE ON THE FIBULAR SIDE - GREEN ARROWS, WHERE THE OSTEOINTEGRATION ALREADY STARTED." SUMMARY OF CONCLUSIONS OF MEDICAL CONSULTANT: FEMALE PATIENT AGE 72, WITH REDUCED PHYSICAL ACTIVITY AND PROBABLY OSTEOPOROTIC BONE RECEIVED POROUS FEMORAL PS COMPONENT AND TT TIBIAL COMPONENT. BOTH OF COMPONENTS WERE SLIGHTLY OVERSIZED. THE AGE OF THE PATIENT AS WELL AS REDUCED PHYSICAL ACTIVITY ARE RISK FACTORS FOR THE UNCEMENTED TYPE OF FIXATION AS WELL AS THE POSSIBLE PERIOPERATIVE FRACTURE OF THE MEDIAL TIBIAL EPICONDYLE. ON THE POST OPERATIVE X-RAYS SIGNS OF LACK OF FULL BONY CONTACT WITH BOTH COMPONENTS. COLLAPSE OF MEDIAL TIBIAL EPICONDYLE DUE TO THE POSSIBLE PERIOPERATIVE FRACTURE AND LACK OF BONE QUALITY. NO INFORMATION ABOUT THE TRAUMA. REVISION WITH THE CEMENTED TIBIAL COMPONENT WITH THE CEMENTED STEM. OPENING OF THE MEDIAL JOINT SPACE DUE TO THE LACK OF MCL. PROBABLY CORRECT DESIGN FOR THIS TYPE OF BONE AND LIGAMENTOUS LOSS SHOULD BE CCK. IN CONCLUSION, THE CAUSE OF THE REPORTED LOOSENING CANNOT BE DETERMINED WITH CERTAINTY, BUT ACCORDING TO: - CHECK OF DHRS DID NOT HIGHLIGHTED ANY PRE-EXISTING ANOMALIES ON THE PIECES MANUFACTURED WITH LOT NUMBER 2200474. - THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBER INVOLVED. - OUR MEDICAL CONSULTANT OPINION, FAILURE POSSIBLY DUE TO PATIENT BONE QUALITY, POSSIBLE FRACTURE AND INCORRECT CHOICE OF IMPLANTS ACCORDING TO PATIENT CLINICAL CHARACTERISTICS. WE CAN CLASSIFY THE EVENT AS NOT PRODUCT RELATED. THE OCCURRED EVENT IS RELATED TO A SURGICAL FACTOR AND PATIENT'S CONDITION. PMS DATA: ACCORDING TO PMS DATA THE REVISION RATE DUE TO PHYSICA TT TIBIAL PLATES (CODE (B)(4)) LOOSENING IS ABOUT (B)(4). 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. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE PHYSICA TT FIX. TIBIAL TRAY #5, COMMERCIAL CODE 652114050 - LOT #2202412 - STER. #2200182 THE COMPLAINT SOURCE REPORTED THAT THE IMPLANT HAD TILTED. THE REVISION SURGERY DATE WAS (B)(6) 2023, THE DATE OF THE PREVIOUS SURGERY IS (B)(6) 2023. PATIENT IS FEMALE DATE OF BIRTH - (B)(6)1951. APPROX. HEIGHT = 165.00CM. APPROX WEIGHT =69KG. OCCUPATION - RETIRED. ACTIVITY LEVEL = STRONGLY REDUCED. BMI =25.34.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL IMPLANT. THE COMPLAINT SOURCE REPORTED THAT THE IMPLANT HAD TILTED. THE REVISION SURGERY DATE WAS (B)(6) 2023, THE DATE OF THE PREVIOUS SURGERY IS (B)(6) 2023. PATIENT IS FEMALE DATE OF BIRTH - (B)(6) 1951. APPROX. HEIGHT = 165.00CM. APPROX WEIGHT =69KG. OCCUPATION - RETIRED. ACTIVITY LEVEL = STRONGLY REDUCED. BMI =25.34. EXPLANTED COMPONENT INFORMATION. PHYSICA TT FIX. TIBIAL TRAY #6 (CODE: 6521.14.060 - LOT # 2200474 - STER. # (B)(4)). EVENT OCCURRED IN FRANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216451 PHYSICA TT PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #6 UNCEMENTED MBH LIMACORPORATE S.P.A. 6521.14.060 2200474 08033390174299

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention