BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT

    MDR report key: 18377652 · Received December 21, 2023

    Report

    Report Number
    3008021110-2023-00148
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 12, 2023
    Report Date
    April 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBH
    UDI-DI
    08033390174305
    PMA / PMN Number
    K201084
    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 NUMBERS, 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 NUMBERS. A FINAL REPORT WILL BE SENT AFTER THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (LOT. NR. 2218966), NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE WAS DETECTED ON THE 15 TIBIAL PLATES RELEASED WITH LOT NR. 2218966, STER. NR. (B)(4). THEREFORE, WE CAN STATE THAT THEY WERE MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT NUMBER: 2218966. THE EXPLANTED COMPONENT WAS RETURNED TO LIMACORPORATE AND FROM A VISUAL INSPECTION IT SEEMS THAT THERE IS NO BONE GROWTH. THE AVAILABLE INFORMATION AND A PRE-REVISION X-RAY (EXACT DATE UNKNOWN) WERE SHARED WITH A MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HIS COMMENTS ARE REPORTED HEREAFTER: "LOOKING AT THE X-RAYS, I WOULD SAY ONE SIZE BIGGER TT TIBIAL PLATE SHOULD BE USED FOR THE PRIMARY IMPLANTATION. THE TIBIAL SLOPE IS ALSO TOO BIG ON THE LATERAL X-RAY, BUT THIS IS ALREADY AFTER THE TIBIAL LOOSENING OCCURRED. SO, I CANNOT COMMENT IF EXCESSIVE SLOPE WAS ALREADY DONE AT PRIMARY OPERATION. IF THE PATIENT IS YOUNG AND ACTIVE, AN UNDERSIZED TT TIBIAL PLATE WITH TOO EARLY AND TOO ACTIVE PATIENTS CAN LEAD TO THE EARLY FAILURE OF THE TT TIBIA. IN THIS CASE I WOULD SAY THE PATIENT WAS TOO MUCH ACTIVE IN THE EARLY PHASE OF POST-OPERATIVE REHABILITATION AFTER PRIMARY TKA AND THEREFORE EARLY TIBIAL LOOSENING OCCURRED " IN CONCLUSION, THE CAUSE OF THE REPORTED LOOSENING CANNOT BE DETERMINED WITH CERTAINTY, BUT ACCORDING TO OUR MEDICAL EXPERT OPINION, ONE SIZE BIGGER TT TIBIAL PLATE SHOULD BE USED FOR THE PRIMARY IMPLANTATION AND IN ADDITION MAYBE THE PATIENT WAS TOO MUCH ACTIVE IN THE EARLY PHASE OF POST-OPERATIVE REHABILITATION AFTER PRIMARY TKA AND THEREFORE EARLY TIBIAL LOOSENING OCCURRED. THIS EVENT IS CLASSIFIED AS NOT PRODUCT RELATED. 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 PERFORMED ON (B)(6) 2023, DUE TO EARLY MOBILIZATION OF PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. 2200275). DURING THE PROCEDURE PHYSICA CEMENTED TIBIAL PLATED SIZE 7 WAS IMPLANTED. THE FOLLOWING DEVICES WERE EXPLANTED DURING REVISION: PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. 2200275). PHYSICA PS TIBIAL LINER #7 (PRODUCT CODE: 6535.50.710, LOT. NR. 22BC06G, STER. NR. 2200141). THE FOLLOWING DEVICES REMAINED IMPLANTED: PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT. NR. 1811518, STER. NR. 1800255). FEMORAL COMPONENT #7 LEFT (PRODUCT CODE: 6515.10.570, LOT NR. 2109698, STER. NR. 2100357) EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO EARLY MOBILIZATION OF PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. (B)(4)). THE FOLLOWING DEVICES WERE EXPLANTED DURING REVISION: PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. (B)(4)) - SOLD IN US. PHYSICA PS TIBIAL LINER #7 (PRODUCT CODE: 6535.50.710, LOT. NR. 22BC06G, STER. NR. (B)(4)) - SOLD IN US. THE FOLLOWING DEVICES REMAINED IMPLANTED: PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT. NR. 1811518, STER. NR. (B)(4)). FEMORAL COMPONENT #7 LEFT (PRODUCT CODE: 6515.10.570, LOT NR. 2109698, STER. NR. (B)(4)). EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306002 PHYSICA TT PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED MBH LIMACORPORATE S.P.A. 6521.14.070 2218966 08033390174305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention