BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 26MM 3 PEG IMPLANT

    MDR report key: 17715824 · Received September 8, 2023

    Report

    Report Number
    1038671-2023-02215
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314260
    PMA / PMN Number
    K160484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION; (D10) CONCOMITANT DEVICE(S): 7147118 02-020-11-0320 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2; 6778800 02-022-45-2015 - TRULIANT TRAY, CEM SZ 2F/1.5T; A223511 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 7309028 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 7309050 201-78-81 - 3" TROCAR, MOD. HEX 2PK; S428025 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; 7147118 02-022-35-2011 - TRULIANT TIB IMP PS INSERT SZ 2 11MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE PATELLAR TRACKING ISSUE REPORTED CANNOT BE CONFIRMED AND CONTRIBUTING FACTORS FROM PATIENT OR USER-RELATED ISSUES CANNOT BE DETERMINED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. PATELLA SUBLUXATION MAY BE SECONDARY TO A COMBINATION OF ISSUES INCLUDING IMPLANT ALIGNMENT, INSUFFICIENT PATELLAR RESECTION, AND/OR SOFT-TISSUE IMBALANCES. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 74 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 MONTH POST OP. THE PATIENT HAD AN ISSUE WITH THE PATELLA TRACKING, SO THE SURGEON WAS GOING TO REVISE THE PATELLA. DURING SURGERY HE FOUND NOTHING WRONG WITH THE PATELLA IMPLANT, EXCISED MORE TISSUE AROUND THE PATELLA AND DOWNSIZED THE 9MM POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - THE HOSPITAL KEEPS EXPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113025 ADVANCED PATELLA 26MM 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862314260

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female