BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT TIBIAL PLATE #5

    MDR report key: 18607416 · Received January 30, 2024

    Report

    Report Number
    3008021110-2024-00008
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    December 19, 2023
    Report Date
    May 27, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBH
    PMA / PMN Number
    K201084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED, THEREFORE WE CAN STATE THE DEVICES HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED FOR THE LOT NUMBERS INVOLVED. ACCORDING TO OUR RECORDS, AT LEAST 29 OUT OF 30 WITH LOT. 2301067 - STER. 2300048 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NR. ACCORDING TO OUR RECORDS, AT LEAST 8 OUT OF 8 WITH LOT. 2222424 - STER. 2300023 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NR. ACCORDING TO OUR RECORDS, AT LEAST 17 OUT OF 18 WITH LOT. 2117937 - STER. 2100381HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NR. ACCORDING TO OUR RECORDS, AT LEAST 66 OUT OF 72 WITH LOT. 21AT1AV - STER. 2100379 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NR. THE COMPLAINT SOURCE PROVIDED TO LIMACORPORATE TWO POST-OP X-RAYS AND PHOTOS FROM THE REVISION SURGERY. THE RECEIVED X-RAYS AND PHOTOS WERE SENT TO A MEDICAL EXPERT FOR EVALUATION. UNFORTUNATELY, THESE DOCUMENTS WERE NOT ENOUGH FOR THE MEDICAL EXPERT TO GIVE AN EVALUATION. THEREFORE, FURTHER X-RAYS (ESPECIALLY PRE-OPERATIVE) WERE REQUESTED TO COMPLAINT SOURCE, BUT THESE WERE NOT PROVIDED TO LIMACORPORATE. IN CONCLUSION, CONSIDERING THAT: 1) THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED IN THE EVENT HAVE BEEN CHECKED WITHOUT FINDING ANY PRE-EXISTING ANOMALY. 2) X-RAYS AND ADDITIONAL INFORMATION PROVIDED WERE NOT SUFFICIENT FOR THE MEDICAL EXPERT TO BE ANALYZED WE ARE NOT ABLE TO FURTHER INVESTIGATE THE EVENT, HOWEVER BASED ON THE FEW AVAILABLE INFORMATION RECEIVED WE CAN CLASSIFY THE EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE DUE TO INFECTION OF PHYSICA TT FIX. TIBIAL (FAMILY CODE: 6521.14.XXX), OF ABOUT 0,08%. NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. THIS IS AN MDR FINAL REPORT.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED, THEREFORE WE CAN STATE THE DEVICES HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    DURING A KNEE REVISION SURGERY PERFORMED ON (B)(6), 2023, DUE TO LOOSENING OF PHYSICA TT TIBIAL PLATE CAUSED BY INFECTION, THE ENTIRE PHYSICA PROTHESIS WAS REMOVED. A KNEE SPACER WAS PLACED, CEMENT WITH GENTAMICIN AND VANCOMYCIN. PRODUCTS EXPLANTED DURING SURGERY: PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT. 2301067 - STER. 2300048). PS FEMORAL COMPONENT #5 LEFT (PRODUCT CODE: 6515.10.550, LOT. 2222424 - STER. 2300023). PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT. 2117937 - STER. 2100381). PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE: 6535.50.510 , LOT. 21AT1AV - STER. 2100379). PREVIOUS SURGERY PERFORMED ON (B)(6), 2023. PATIENT IS A FEMALE, 65 YEARS OLD, HEIGHT: 160 CM , WEIGHT: 65 KG, HOUSEWIFE, EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO LOOSENING OF PHYSICA TT TIBIAL PLATE CAUSED BY INFECTION. THE ENTIRE PHYSICA PROTHESIS WAS REMOVED AND G21 KNEE SPACER WAS PLACED, CEMENT WITH GENTAMICIN AND VANCOMYCIN. PRODUCTS EXPLANTED DURING SURGERY: PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT. 2301067 - STER. 2300048) PS FEMORAL COMPONENT #5 LEFT (PRODUCT CODE: 6515.10.550, LOT. 2222424 - STER. 2300023) PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT. 2117937 - STER. 2100381) PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE: 6535.50.510 , LOT. 21AT1AV - STER. 2100379) PREVIOUS SURGERY PERFORMED ON (B)(6) 2023. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537522 PHYSICA TT TIBIAL PLATE #5 PHYSICA TT FIX. TIBIAL TRAY #5 MBH LIMACORPORATE S.P.A. 6521.14.050 2117937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention