BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CR FEM RT SZ 6 CEM

    MDR report key: 14166820 · Received April 21, 2022

    Report

    Report Number
    1818910-2022-07191
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 21, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295041214
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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

    REVISION RIGHT TOTAL KNEE REPLACEMENT FOR INSTABILITY, EVIDENCE OF HAEMARTHROSIS AND STAINED "THOUGHT TO BE BLOOD" SYNOVIUM. BEARING CHANGED TO THICKER BEARING.

    Description of Event or Problem · 0

    1. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF ATTUNE CR FB INSRT SZ 6 7MM (151620607)? NO. 2. WERE THERE ANY PATIENT CONDITIONS OR TRAUMA/S THAT LED TO THE INSTABILITY? NO. 3. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. 4. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. 5. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. 6. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. 7. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? NO. 8. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S). IF YES, PLEASE PROVIDE DETAILS. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921504 ATTUNE CR FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL NJL DEPUY IRELAND - 9616671 1504-00-206 8793081 10603295041214

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention ATTUNE CR FB INSRT SZ 6 7MM| ATTUNE FB TIB BASE SZ 6 CEM| ATTUNE MEDIAL DOME PAT 41MM