BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS FEMORAL RT SZ 7 CEM

    MDR report key: 13117320 · Received December 30, 2021

    Report

    Report Number
    1818910-2021-28989
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 30, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295042303
    PMA / PMN Number
    K160700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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.

    Description of Event or Problem · 0

    SUBJECT ID: 12-006. STUDY: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR SLID OUT OF A WHEELCHAIR AND SUFFERED A PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION OF FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017221 ATTUNE CRS FEMORAL RT SZ 7 CEM KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-40-207 J18X70 10603295042303

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention ATTUNE CEMENTED STEM 16X80MM.| ATTUNE CRS FEMORAL RT SZ 7 CEM.| ATTUNE DIST FEM AUG SZ 7 4MM.| ATTUNE MEDIAL DOME PAT 38MM.| ATTUNE POS FEM AUG SZ 7 4MM.| ATTUNE PS RP INSRT SZ7 6MM.| ATUN PRESSFIT STR STEM14X110MM.| ATUN TIB AUG UNIV SZ 7/8 5MM.| ATUN TIB SLV M/L 29MM FULL POR.| ATUNE REV RP TIB BASE SZ 7 CEM.| SMARTSET HV BONE CEMENT 40G.| SMARTSET HV BONE CEMENT 40G.