BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 8845450 · Received July 31, 2019

    Report

    Report Number
    1818910-2019-99711
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    June 7, 2018
    Report Date
    November 12, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168379
    PMA / PMN Number
    K081155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT : 7997129. DEVICE HISTORY REVIEW : A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW ON COM-193607 DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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) USED TO CAPTURE MEDICAL DEVICE REMOVAL. 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 TO ADDRESS LOOSENING OF THE TIBIA TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS DEPUY. POLY HAD EXCESSIVE PITTING, KNEE WAS REVISED WITH FB REVISION TRAY AND NEW CR POLY. NO FURTHER PATIENT AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2018, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642959 SMARTSET MV 40G - EO BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3122-040 7997129 10603295168379

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention