BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4

    MDR report key: 16005509 · Received December 19, 2022

    Report

    Report Number
    1038671-2022-01608
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    January 9, 2020
    Report Date
    January 18, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314567
    PMA / PMN Number
    K170240
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT CONDITION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN RELATED TO THE PATIENT CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. PATELLAR CLUNK IS CAUSED BY A FIBROUS NODULE OF SCAR TISSUE AT THE POSTERIOR SURFACE OF THE DISTAL QUADRICEPS TENDON/SUPERIOR PATELLAR POLE CATCHING ON THE BOX OF THE FEMORAL COMPONENT DURING KNEE EXTENSION (PATELLAR CLUNK SYNDROME (B)(6) 2021). CONCOMITANT DEVICE(S): 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4, (B)(4), 02-022-35-4009 - TRULIANT TIB IMP PS INSERT SZ 4 9MM, (B)(4). SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T, (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4, (D4) CATALOG NUMBER: 02-020-11-0340, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 06-SEP-2027, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D10) CONCOMITANT DEVICE(S): 02-022-35-4009 - TRULIANT TIB IMP PS INSERT SZ 4 9MM, S028289, SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T, 5789055, 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT 6187770, (G4) PMA/510(K)NUMBER: K170240, (H4) DEVICE MANUFACTURE DATE: 06-SEP-2017.

    Description of Event or Problem · 0

    AS REPORTED BY THE TRUILANT KNEE CLINICAL STUDY, THIS 65 Y/O OBESE FEMALE PATIENT WAS EXPERIENCING PATELLAR CLUNK SYNDROME, PATIENT DECLINED SURGICAL INTERVENTION (ARTHROSCOPY) AT THIS TIME. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126460 TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 200-07-32 UNK 10885862314567

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention SEE H10