BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 20419454 · Received October 10, 2024

    Report

    Report Number
    1038671-2024-03922
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    October 3, 2024
    Report Date
    July 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REVISION REPORTED WAS DUE TO THE REPORTED PAIN WHICH WAS THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL AND BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. PROSTHESIS WEAR OF THE PATELLA COULD NOT BE CONFIRMED AS IMAGES OF THE EXPLANTED DEVICE WERE NOT PROVIDED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 02-012-44-3013 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM 3548061 02-022-45-9999 - FIT TRAY REVISION ADD UNASSIGNED 02-012-44-3013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM 3548061 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM 4690744 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM 5818259 02-010-66-2002 - METAPHYSEAL FEMORAL CONE, MEDIUM, H42MM 5860435 02-012-60-1480 - TRU STEM EXT 14MM X 80MM 6026007 02-012-60-1680 - TRU STEM EXT 16MM X 80MM 6287721 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T 6309047 02-010-06-0532 - TRU POST. AUG. SIZE 3, 10MM 6370078 02-010-06-0230 - TRU CC FEMORAL SIZE 3 LEFT 6593212 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM 6765258 204-70-00 - TIBIAL STEM EXT. SCREW 6774151 201-78-81 - 3" TROCAR, MOD. HEX 2PK 6837376 201-78-81 - 3" TROCAR, MOD. HEX 2PK 6954490.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 YEARS AND 1 MONTH POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED TO COMPETITOR DEVICES. THE PATIENT HAS A RECALLED INSERT AND PATELLA. THIS IS THE FOURTH SURGERY FOR THIS PATIENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. RELATED REPORT NUMBER 1038671-2024-03920

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946455 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention SEE H11