BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CMW 3 40G

    MDR report key: 7475651 · Received May 1, 2018

    Report

    Report Number
    1818910-2018-58619
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    February 28, 2017
    Report Date
    October 31, 2019
    Manufacturer
    DEPUY CMW- 9610921
    Product Code
    LOD
    UDI-DI
    10603295168638
    PMA / PMN Number
    K053003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.  UDI: (B)(4). ADDED: B5, B7 AND H6 (SURGICAL INTERVENTION).

    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. ADDED: H6 (PATIENT). H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE MEDICAL DEVICE REMOVAL.

    Description of Event or Problem · 0

    MEDICAL RECORDS ALLEGES ADHESIONS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. 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

    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

    MEDICAL RECORDS RECEIVED 05 APR 2018. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION TO ADDRESS PAIN, STIFFNESS, AND LOOSENING OF THE FEMORAL IMPLANT AT THE CEMENT/IMPLANT INTERFACE AND LOOSENING OF THE TIBIAL IMPLANT AT UNKNOWN INTERFACE. DEPUY CEMENT WAS UTILIZED. DURING THE PROCEDURE THERE WERE SCREWS AND PORTION FEMORAL PLATE REMOVED FROM PREVIOUS FRACTURE PLACED PRIOR TO INITIAL KNEE ARTHROPLASTY (BOTH OF UNKNOWN MANUFACTURER). DOI: (B)(6) 2015; DOR: (B)(6) 2017; (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318569 DEPUY CMW 3 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW- 9610921 3332-040 7944655 10603295168638

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention ATTUNE MEDIAL DOME PAT 38MM| ATTUNE MEDIAL DOME PAT 38MM