BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 10258959 · Received July 10, 2020

    Report

    Report Number
    1818910-2020-15559
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 30, 2020
    Report Date
    June 30, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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.

    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. DEVICE HISTORY LOT DEVICE HISTORY REVIEWED: 8378515. 0 NON-CONFORMANCES ON THIS LOT NUMBER FINAL MICRO AND STERILITY TESTS PASSED ALL QC RELEASE SPECIFICATIONS MET 2760 UNITS RELEASED LOT EXPIRY DATE: 31 AUGUST 2018.

    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. DMF#: (B)(4). TRADE NAME: GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S): GENTAMICIN SULPHATE, DOSAGE FORM: POWDER, STRENGTH: 1.0G ACTIVE IN OUR CEMENTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. E3 INITIAL REPORTER OCCUPATION: LAWYER.

    Description of Event or Problem · 0

    REVISION OPERATIVE NOTE FROM (B)(6) 2020 INDICATED THE PATIENT UNDERWENT THE REVISION FOR PAIN AND SWELLING. INFECTION WAS RULED OUT. THE FEMORAL COMPONENT AND PATELLA WERE NOTED TO BE WELL FIXED. SYNOVIAL HYPERTROPHIC CHANGES WERE NOTED. OSTEOLYSIS WAS ALSO NOTED.

    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

    THE PATIENT WAS REVISED TO ADDRESS SUSPECTED LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. CONFIRMED TO BE GROSSLY LOOSE WITH NO CEMENT ADHERENCE TO THE BACKSIDE OF THE IMPLANT. PITTING WAS OBSERVED ON THE POLY INSERT. REVISED TO RP REVISION ATTUNE TRAY AND SLEEVE AND STEM. BMI 40.9. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722981 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-50-501 8378515 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FEM LT SZ 7 CEM| ATTUNE PS RP INSRT SZ 7 10MM| ATTUNE RP TIB BASE SZ 7 CEM| SMARTSET GMV 40G US EO| ATTUNE PS RP INSRT SZ 7 10 MM| ATTUNE RP TIB BASE SZ 7 CEM| SMARTSET GMV 40G US EO