BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 5

    MDR report key: 17097027 · Received June 9, 2023

    Report

    Report Number
    1038671-2023-01301
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    May 2, 2023
    Report Date
    March 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314475
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK 4976625. 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK 4915628. 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5 4876544. 02-022-35-5011 - TRULIANT TIB IMP PS INSERT SZ 5 11MM 4906188. 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T 4894512. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 4869655. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 4961600. 201-78-18 - HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK 4558913. 02-020-11-0250 - TRULIANT PS CEM FEM PS CEM LEFT SZ 5 (B)(6). 02-022-35-5013 - TRULIANT TIB IMP PS INSERT SZ 5 13MM 4850786. 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T 5042422. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 5441520.

    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, E THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING, THE REPORTED PAIN, 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 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, APPROXIMATELY 5 YEARS POST OP INITIAL LEFT TKA, THIS 74 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551917 TRULIANT PS CEM FEM PS CEM LEFT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862314475

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male