BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CMW 1 40G

    MDR report key: 11223570 · Received January 25, 2021

    Report

    Report Number
    1818910-2021-01763
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 13, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168614
    PMA / PMN Number
    P960001
    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). 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. 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. DEVICE HISTORY LOT : LOT NUMBER: 9242513, PRODUCT CODE: 3312040 , (B)(4) UNITS RELEASED, LOT EXPIRY DATE: 31 JULY 2022 . 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. ALL QC RELEASE SPECIFICATIONS MET. DEVICE HISTORY REVIEW : 1 UNRELATED NON-CONFORMANCE ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. ALL QC RELEASE SPECIFICATIONS MET.

    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 DVT AND HEMARTHROSIS THAT RESULTED FROM BLOOD THINNING MEDICATION TO TREAT DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118336 DEPUY CMW 1 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3312-040 9242513 10603295168614

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DEPUY CMW 1 40G| PFC*SIGMA C/R NPOR FEM RT SZ 4| PFC*SIGMA/OV/DOME PAT 3PEG,41| SIG MOD TIB TRAY CEM COCR 4| SIGMA PLI XLK INS 4 12.5MM| DEPUY CMW 1 40G| PFC*SIGMA C/R NPOR FEM RT SZ 4| PFC*SIGMA/OV/DOME PAT 3PEG,41| SIG MOD TIB TRAY CEM COCR 4| SIGMA PLI XLK INS 4 12.5MM