BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE FB TIB BASE SZ 3 CEM

    MDR report key: 20903575 · Received December 11, 2024

    Report

    Report Number
    1818910-2024-25194
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 26, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295492054
    PMA / PMN Number
    K170806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT ==> THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 26/NOV/2024, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM. CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM. CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED. CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3. CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3. CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS. CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570322 ATTUNE FB TIB BASE SZ 3 CEM KNEE TIBIAL TRAY JWH DEPUY IRELAND - 9616671 9854210 10603295492054

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention AMK FIXATION PINS 1/8 DIA X 3| ATTUNE CR FEM LT SZ 3 CEM| ATTUNE MEDIAL DOME PAT 32MM| ATUNE CR LT MS INS SZ 3 8| DEPUY CMW 1 40G| HP STRL THREADED PINS HEADED