BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS FEMORAL RT SZ 7 CEM

    MDR report key: 20590637 · Received November 1, 2024

    Report

    Report Number
    1818910-2024-22918
    Event Type
    Injury
    Date Received
    November 1, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295042303
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT). CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES: CLINICAL ADVERSE EVENT RECEIVED FOR ENTRAPMENT RAMUS INFRAPATELLARIS. DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK DECEMBER 2020, DATE OF IMPLANT: ON (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NEURECTOMIE. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440207, LOT NUMBER ID: HF5013, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4).

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR ENTRAPEMENT RAMUS INFRAPATELLARIS DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK DECEMBER 2020 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2019 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799880 ATTUNE CRS FEMORAL RT SZ 7 CEM KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US HF5013 10603295042303

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention ATTUN REV OFFST STM ADPTR 4MM.| ATTUN REV OFFST STM ADPTR 6MM.| ATTUNE DIST FEM AUG SZ 7 8MM.| ATTUNE DIST FEM AUG SZ 7 8MM.| ATTUNE POS FEM AUG SZ 7 4MM.| ATTUNE POS FEM AUG SZ 7 8MM.| ATUNE CRS FB TIB BASE SZ 5 CEM.| ATUNE PRESSFIT STR STEM12X60MM.| ATUNE PRESSFIT STR STEM16X60MM.