BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15625017 · Received October 18, 2022

    Report

    Report Number
    1038671-2022-01317
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 12, 2016
    Report Date
    January 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041227
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 13A2101 - CEMEX SYSTEM FAST GENTA 70G, AA1808; 200-02-32 - THREE PEG PATELLA 32MM, 1266716; 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T, 1283339; 201-78-14 - HOLDING PIN HEADLESS SHARP POINT LONG 4PK, 1060803; 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 1227662, 1227663; 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM, 82165; 230-02-02 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2, 1175411; ASA0030 - STERILE DISPOSABLE CONTAINERS, AA1362. RECALL: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    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; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, DISASSEMBLY, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 LEFT TKA ON (B)(6) 2008. THE PATIENT HAD A REVISION ON (B)(6) 2016. UPON INFORMATION AND BELIEF THE LOOSE COMPONENTS AND OSTEOLYSIS IN THE PATIENT'S LEFT KNEE WERE DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483412 CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++ PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-72-11 10885862041227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10