BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 4, 9MM, SLOPE +

    MDR report key: 17136506 · Received June 15, 2023

    Report

    Report Number
    1038671-2023-01361
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    March 27, 2023
    Report Date
    February 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041104
    PMA / PMN Number
    K932690
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 934060 200-04-44 - CEMENTED FINNED TIB. TRA SZ 4F/4T. 1021260 200-02-38 - THREE PEG PATELLA 38MM. 1047606 230-02-04 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4. 1119077 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 1134519 201-78-14 - HOLDING PIN HEADLESS SHARP POINT LONG 4PK. 78108 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM. AA1237 ASA0030 - STERILE DISPOSABLE CONTAINERS. AA1808 13A2101 - CEMEX SYSTEM FAST GENTA 70G.

    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 AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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 VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6)2008. THEY HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 15 YEARS AFTER THEIR INITIAL IMPLANTATION. PREOPERATIVELY THERE WERE SIGNS OF SOME OSTEOLYSIS AROUND THE IMPLANT BUT NO CLEAR SIGN THAT THE IMPLANT WAS LOOSE. HOWEVER, THERE WAS SIGNIFICANT NARROWING ON THE MEDIAL SIDE OF THE IMPLANT SUGGESTING EXCESSIVE POLYETHYLENE WEAR. POSTOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR OF LEFT TOTAL KNEE REPLACEMENT WITH ASEPTIC TIBIAL LOOSENING. PATELLA COMPONENT SHOWED SOME WEAR BUT WAS NOT EXTENSIVE. THE PATELLA BUTTON SEEMED TO BE WELL FIXED AND WAS LEFT AS IS. THE POLYETHYLENE HAD WORN THROUGH COMPLETELY IN THE POSTERIOR MEDIAL CORNER AND HAD DISRUPTED THE LOCKING MECHANISM ON THE POLYETHYLENE. THE FEMORAL COMPONENT APPEARED TO BE FIXED, BUT THE TIBIAL COMPONENT WAS LOOSE, AS IT HAD SOME MOTION. THERE WAS MOTION UNDERNEATH THE TRAY AND FLUID MOVING IN AND OUT ON THE MEDIAL SIDE. THERE WAS A LITTLE BIT OF A OSTEOLYTIC CYST ON THE LEFT MEDIAL FEMORAL CONDYLE BUT WAS CONTAINED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094255 CR TIBIAL INSERT SZ 4, 9MM, SLOPE + PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 200-64-09 UNK 10885862041104

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention SEE H10.