BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE MEDIAL DOME PAT 41MM

    MDR report key: 11877631 · Received May 25, 2021

    Report

    Report Number
    1818910-2021-11126
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    OIY
    UDI-DI
    10603295056706
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. H10 ADDITIONAL NARRATIVE: H6 HEALTH EFFECT - CLINICAL CODE: APPROPRIATE TERM / CODE NOT AVAILABLE (E2402) USED TO CAPTURE THE INFECTIONS (E19).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. PATIENT HAD A LEFT TKA (B)(6) 2020 AND EXPLANTED LEFT TKA ON (B)(6) 2021. 41 PATELLA, 7 LEFT PS FEMUR, 7/6 MM RP ATTUNE POLY AND 8 ATTUNE RP TRAY. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777875 ATTUNE MEDIAL DOME PAT 41MM ATTUNE IMPLANT : KNEE PATELLA OIY DEPUY IRELAND - 9616671 1518-20-041 9390677 10603295056706

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FEM LT SZ 7 CEM| ATTUNE PS RP INSRT SZ7 6MM| ATTUNE RP TIB BASE SZ 8 CEM| COMPETITOR CEMENT| ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FEM LT SZ 7 CEM| ATTUNE PS RP INSRT SZ7 6MM| ATTUNE RP TIB BASE SZ 8 CEM| COMPETITOR CEMENT