BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CMW 2 20G

    MDR report key: 9281189 · Received November 5, 2019

    Report

    Report Number
    1818910-2019-114222
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168621
    PMA / PMN Number
    K053003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED TO THE INVESTIGATION SITE FOR EVALUATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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

    SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (RIGHT KNEE). TREATMENT/INTERVENTION: IRRIGATION & DEBRIDEMENT. DEPUY COMPONENTS: CATALOG ID: 196192032; LOT: 9099337; DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 12.5MM. CATALOG ID: 940013; LOT: 476347; DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 LT. CATALOG ID: 960102; LOT: D19061311; DESCRIPTION: OVAL DOME PATELLA 3 PEG SZ 38. CATALOG ID: 129433140; LOT: 9227776; DESCRIPTION: MBT CEMENTED KEEL SZ 4. CATALOG ID: 3322020; LOT: 9102851; DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020; LOT: 9102851; DESCRIPTION: SMART SET BONE CEMENT 20G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074983 DEPUY CMW 2 20G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 9102851 10603295168621

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention