BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++

    MDR report key: 14933644 · Received July 6, 2022

    Report

    Report Number
    1038671-2022-00757
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 15, 2022
    Report Date
    February 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041227
    PMA / PMN Number
    K932690
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE EVALUATED BY MFR) PENDING EVALUATION.

    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; NO REASON FOR REVISION WAS GIVEN. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) AS REPORTED BY LEGAL THAT THIS FEMALE PATIENT HAD A REVISION ON HER RIGHT KNEE ON (B)(6)2015. PATIENT HAD BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2012. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF ADDITIONAL INFORMATION, FIELDS D1, D4, D10, AND H6 HAVE BEEN UPDATED. ADDED INFORMATION TO D8. D10. CONCOMITANTS: 13A2101 - CEMEX SYSTEM FAST GENTA 70G SN: (B)(6), 200-03-32 - ONE PEG PATELLA 32MM SN: (B)(6), 200-04-23 - CEMENTED FINNED TIB. TRA SZ 2F/3T SN: (B)(6), 200-22-13 - CR TIBIAL INSERT SZ 2, 13MM SN: (B)(6), 232-02-02 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 2, LEFT SN: 1882105, 232-03-02 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 2, RIGHT SN: (B)(6), 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS SN: (B)(6), 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02 SN: (B)(6) H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND AN INSUFFICIENT BOND BETWEEN THE TIBIAL COMPONENT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) TIBIAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND TIBIAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION - H7 & H9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A REVISION ON HER RIGHT KNEE. REASON FOR THE REVISION WAS NOT REPORTED.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL THAT THIS FEMALE PATIENT HAD A REVISION ON HER RIGHT KNEE ON (B)(6)2015. PATIENT HAD BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2012. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030030 CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++ PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862041227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.