BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE CRS RP INSRT SZ 6 6MM

    MDR report key: 10285864 · Received July 16, 2020

    Report

    Report Number
    1818910-2020-16115
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    February 28, 2019
    Report Date
    July 6, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295056010
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. A WORLDWIDE COMPLAINT DATABASE SEARCH DID IDENTIFY OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. IT WAS CONFIRMED THAT ALL OF THE PREVIOUS COMPLAINTS ALSO REFERENCED THE CLINICAL STUDY DSJ-2016-03 & SUBJECT I/D 23-004. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED.

    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

    CLINICAL ADVERSE EVENT RECEIVED FOR PAIN FRONT SIDE TARGET KNEE AND LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND SURGICAL KNEE MANIPULATION UNDER ANESTHESIA INTERVENTION (NO REVISION OF PRODUCTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745616 ATTUNE CRS RP INSRT SZ 6 6MM KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 1517-10-606 8834428 10603295056010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ATTUNE CEMENTED STEM 14X50MM| ATTUNE CEMENTED STEM 14X50MM| ATTUNE CRS FEMORAL RT SZ 6 CEM| ATTUNE CRS RP INSRT SZ 6 6MM| ATUN TIB SLV M/L 29MM HALF POR| ATUNE REV RP TIB BASE SZ 7 CEM| COMPETITOR BONE CEMENT| COMPETITOR BONE CEMENT