BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2, 13MM

    MDR report key: 15426451 · Received September 15, 2022

    Report

    Report Number
    1038671-2022-01121
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    July 22, 2022
    Report Date
    March 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174260
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 5895759, 02-020-13-0320 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 2 5815939, 02-022-47-2009 - TRULIANT TIB IMP CR INS STD SZ 2, 9MM 5376583, 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT AB3885, 200-02-35 - THREE PEG PATELLA 35MM 6038558, 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM 5775056, 204-70-00 - TIBIAL STEM EXT. SCREW 6018930.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS MOST LIKELY DUE TO PROSTHESIS WEAR. IT IS POSSIBLE THAT A CONTRIBUTING FACTOR TO THE WEAR OF THE TIBIAL INSERT MAY HAVE BEEN RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. HOWEVER, THE PROSTHESIS WEAR AND CONTRIBUTIONS FROM IMPLANT POSITIONING, INSTABILITY, AND/OR PATIENT-RELATED FACTORS TO THE SEQUENCE OF EVENTS CANNOT BE CONFIRMED AS THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AND LIMITED CLINICAL INFORMATION WAS PROVIDED. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. CORRECTED FIELDS: H6-CLINICAL CODES, MEDICAL DEVICE PROBLEM CODE AND COMPONENT CODE. D10: 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (B)(6), 02-020-13-0320 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 2 (B)(6), 02-022-47-2009 - TRULIANT TIB IMP CR INS STD SZ 2, 9MM (B)(6), 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT (B)(6), 200-02-35 - THREE PEG PATELLA 35MM (B)(6), 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM (B)(6), 204-70-00 - TIBIAL STEM EXT. SCREW (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FRACTURE, TIBIAL LOOSENING, AND PATELLAR LOOSENING. OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED DUE TO WEAR IN THE LINER/TIBIAL COMPONENTS. THE TIBIA, LINER AND PATELLA WERE REVISED TO EXACTECH PRODUCTS. THERE WAS NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE FINDINGS NOTED SIGNIFICANTLY LOOSE PATELLA AND TIBIAL COMPONENTS WITH BONE LOSS MEDIALLY AND A FRACTURED POLYETHYLENE ANTEROMEDIALLY AND POSTEROLATERALLY. INTRAOPERATIVELY IT WAS NOTED THE FEMUR DEMONSTRATED IT DID NOT APPEAR TO BE LOOSE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270919 LOGIC CR TIB INSERT STD, SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 13MM 10885862174260

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| R SEE H10| SEE H11