BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 23896445 · Received December 26, 2025

    Report

    Report Number
    1038671-2025-03617
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    February 8, 2024
    Report Date
    December 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 02-012-51-5009 - LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM, (B)(6) - 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT, SZ 5 , (B)(6) - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6) - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6) - 201-78-81 - 3 TROCAR, MOD. HEX 2PK , (B)(6) - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED , (B)(6) - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED , (B)(6) - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS , 9019020015 - (B)(6) - GPS IMPLANT KIT V2. G2: AUSTRALIA H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2024-00418. NO DEVICE WAS NOT RETURNED FOR EVALUATION; RADIOGRAPH IMAGES WERE PROVIDED OF THE FEMORAL COMPONENTS; HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE REVIEW IDENTIFIED THERE APPEARS TO BE BIOLOGICAL FLUID ON THE BACKSIDE OF THE FEMORAL COMPONENT. THE DISCOLORATION ON THE BACKSIDE OF THE FEMORAL COMPONENT APPEARS CONSISTENT WITH EXPOSURE TO BONE CEMENT. HOWEVER, THERE DOES NOT APPEAR TO BE RETAINED BONE OR BONE CEMENT ON THE BACKSIDE OF THE FEMORAL COMPONENT VISIBLE IN THE PROVIDED IMAGE. IMAGES OF THE TIBIAL INSERT AND PATELLA COMPONENTS WERE NOT PROVIDED WITH THE COMPLAINT SUBMISSION; THEREFORE, THE PROSTHESIS WEAR CANNOT BE CONFIRMED. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. EXACTECH HAS DISCOVERED THAT A BAG USED IN THE PACKAGING OF OUR POLYETHYLENE INSERTS HAD BEEN PRODUCED OUTSIDE OF OUR QUALITY SPECIFICATIONS. THE USE OF THESE NONCONFORMING BAGS MAY ENABLE INCREASED OXYGEN DIFFUSION TO THE UHMWPE (ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE) INSERT, RESULTING IN INCREASED OXIDATION OF THE MATERIAL RELATIVE TO INSERTS PACKAGED WITH BAGS THAT CONFORM TO EXACTECH¿S SPECIFICATIONS. FOR INSERTS WITH GREATER THAN FIVE YEARS OF SHELF LIFE, INCREASED OXIDATION OF THE INSERTS CAN LEAD TO PREMATURE POLYETHYLENE WEAR RESULTING IN A REVISION SURGERY. HOWEVER, WHILE IT WAS PACKAGED IN A NON-CONFORMING VACUUM BAG, THIS TIBIAL INSERT WAS ON THE SHELF FOR LESS THAN 5 YEARS BEFORE IT WAS IMPLANTED. THE NON-CONFORMING BAGS WERE ALSO USED IN THE PACKAGING OF OUR PATELLA COMPONENTS. PATELLA COMPONENTS PACKAGED IN NON-EVOH VACUUM BAGS, WHICH HAVE A MAXIMUM 5-YEAR SHELF-LIFE PRIOR TO EXPIRATION, HAVE REDUCED RISK OF OXIDATIVE DEGRADATION. THE PATELLA COMPONENT INVOLVED IN THIS CASE WAS ON THE SHELF FOR 9 MONTHS BEFORE IMPLANTATION. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REVISION REPORTED IN EVENT WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA POSSIBLY DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE ASEPTIC (NONINFECTED) LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT(S) AND THE BONE(S). THE CAUSE OF THE PROSTHESIS WEAR AND REPORTED LOOSENING CANNOT BE DETERMINED BECAUSE THE EXPLANTED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE WHICH COMPONENT(S) WERE FOUND TO BE WORN/LOOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THREE (3) YEARS LATER, THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE DUE TO ASEPTIC LOOSENING OF THE PATELLA COMPONENT AND PROSTHESIS WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY ATTACHED (B)(6) - 02-012-51-5009 - LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH 510K: K123342 . CONCOMITANTS:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210401 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11