BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 20762099 · Received November 22, 2024

    Report

    Report Number
    1038671-2024-04460
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    January 16, 2023
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2024-04459 1038671-2023-01346 RECALL NUMBER: Z-0582-2024 D10: CONCOMITANTS: 16022301 660-01-10 - OSSILIX / FORM 10CC CALCIUM PHOSPHATE 4124267 02-012-60-2012 - TRU STEM EXT 20MM X 120MM 4231073 02-010-06-0250 - TRU CC FEMORAL SIZE 5 LEFT 4243473 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM 4417040 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM 4417041 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM 4845810 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM 4872346 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM 4901712 200-02-38 - THREE PEG PATELLA 38MM 4954951 02-012-60-1212 - TRU STEM EXT 12MM X 120MM 5022823 204-70-00 - TIBIAL STEM EXT. SCREW 5118737 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04459, 1038671-2023-01346 THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0582-2024; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PATELLAR LOOSENING, 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. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REVISION, APPROXIMATELY 62 MONTHS AFTER THEIR INITIAL PROCEDURE. THERE WAS FOUND TO BE A LOOSE TIBIAL COMPONENT WITH A COMPLETELY LOOSE TIBIAL STEM. THERE WAS FOUND TO BE A MODERATE AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS EVIDENCE OF POLYETHYLENE WEAR AND SYNOVIAL ENCAPSULATION. THERE WAS A HETEROTOPIC BONE FORMED AROUND THE PATELLA WITH A LOOSE PATELLAR COMPONENT. THE PATIENT ALSO HAD DEVELOPED A PRETIBIAL GANGLION CYST DUE TO THE LOOSE TIBIAL COMPONENT RUBBING UP AGAINST THE ANTERIOR CORTEX OF HIS MID LEFT TIBIA. 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
    1777818 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R