BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM

    MDR report key: 15546553 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01255
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    January 1, 2021
    Report Date
    August 15, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173713
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 11043016021, A10012 - GPS IMPLANT KIT V2 .4396992, 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5. 4789345, 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. 4894839, 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3.5 YEARS POST OP. REVISION PROCEDURE FOR REASONS UNKNOWN. NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED IN (B)(4) MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND FEMORAL LOOSENING/DEBONDING AS STATED IN THE LEGAL DOCUMENTATION. THE FEMORAL LOOSENING/DEBONDING MAY HAVE BEEN THE RESULT OF FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE. HOWEVER, THIS CANNOT BE CONFIRMED AS DETAILS REGARDING CEMENTING TECHNIQUE OR ENVIRONMENTAL CONDITIONS WERE NOT PROVIDED. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES, PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    B5 AND B6: ADDED ADDITIONAL INFORMATION RECEIVED REGARDING THE COMPLAINT AND UPDATED TESTING SECTION. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS REVISED APPROXIMATELY 3.5 YEARS POST OP. NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3.5 YEARS POST OP. REVISION PROCEDURE FOR REASONS UNKNOWN. NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2021. PATIENT'S PAINFUL SYMPTOMS STILL PERSISTED AFTER THE INITIAL PROCEDURE. ON (B)(6) 2017, PATIENT HAD PAIN AND SWELLING AFTER PHYSICAL THERAPY. ON (B)(6) 2018 THE PATIENT EXPRESSED INTERMITTENT PAIN. X-RAYS WERE TAKEN AND LOOKED NORMAL. ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT KNEE MANIPULATION WITH ANESTHESIA. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2019 THE SYMPTOMS WERE WORSENING WITH PAIN CONSTANT, INSTABILITY AND THE KNEE GIVING WAY. X-RAYS WERE TAKEN AND LOOKED OK. ON (B)(6)2020, THE PATIENT'S SYMPTOMS HAD WORSENED. AGAIN, X-RAYS TAKEN SHOWED NO SIGNS OF LOOSENING OR LUCENCY. AT THAT VISIT, THE DOCTOR HAD A LENGTHY CONVERSATION WITH THE PATIENT AND EXPLAINED TO HIM THAT HIS RESULTS WITH THE KNEE REPLACEMENT DEVICES SHOWED AN UNACCEPTABLE FAILURE RATE AT 2% AT 46 MONTHS AND THAT THIS MAY BE THE EARLY MANIFESTATION OF ACCELERATED POLY-WEAR. THAT AT ANOTHER VISIT ON 5 FEB 2021, THE PATIENT WAS STILL EXPERIENCING PAIN WITH THE EXECTECH LOGIC KNEE REPLACEMENT AND "HE [HAS] NEVER BEEN HAPPY WITH IT." ON EXAM, THERE WAS EFFILSION WITH SOME SWELLING OF THE KNEE. X-RAYS WERE TAKEN AND NO ABNORMALITIES WERE NOTED. ON (B)(6) 2021, THE PATIENT RECEIVED AN ASPIRATION OF THE LEFT KNEE AND YELLOW SYNOVIA FLUID WAS ASPIRATED. IT WAS DESCRIBED TO THE PATIENT AS PLASTIC DETERIORATING WITHIN THE KNEE COMPONENT. ON (B)(6) 2021 THE PATIENT HAD A LEFT KNEE REVISION. THE SURGEON FOUND PREMATURE WEARING OF THE MEDIAL AND LATERAL WEIGHTBEARING SURFACES OF THE TIBIAL IMPLANT. HE DISCOVERED A LARGE AMOUNT OF BLOOD-TINGED SYNOVIAL FLUID AND SYNOVITIS EXPRESSED. HE ALSO FOUND THAT THE FEMORAL IMPLANT HAD DEBONDED FROM ITS CEMENT. THE SURGEON'S POST-OP DIAGNOSIS WAS MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOIN, AND POLYETHELINE WEAR OF LEFT KNEE JOINT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417721 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-44-5009 UNK 10885862173713

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10