BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 9505708 · Received December 20, 2019

    Report

    Report Number
    1818910-2019-124464
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    September 26, 2017
    Report Date
    September 27, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 SYNTHESE JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHESE 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.¿ ADDED: D11 AND H6 (PATIENT). NO CODE AVAILABLE IS USED TO CAPTURE DEVICE REVISION OR REPLACEMENT.

    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 : A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW ON LEGACY COMPLAINT COM-102683 WAS CONDUCTED BY THE MANUFACTURE SITE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES AGAINST THIS LOT. H10 ADDITIONAL NARRATIVE: DETAILS FOR GENTAMICIN COMPONENT OF COMBINATION PRODUCT: ¿ DMF# - (B)(4). ¿ TRADE NAME ¿ GENTAMICIN SULPHATE. ¿ ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. ¿ DOSAGE FORM - POWDER. ¿ STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. CORRECTED: D2B.

    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

    CLINICAL DER STATES THAT PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297320 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US 5450-50-501 3546937 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ATTUNE MEDIAL DOME PAT 35MM.