BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 10586904 · Received September 25, 2020

    Report

    Report Number
    1818910-2020-20923
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    May 1, 2020
    Report Date
    September 14, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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. DETAILS FOR GENTAMICIN COMPONENT OF COMBINATION PRODUCT: DMF# - 13704 , TRADE NAME ¿ GENTAMICIN SULPHATE , ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE , DOSAGE FORM - POWDER , STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT THE SAME/SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 ADVERSE EVENT RECEIVED FOR CHRONIC AND WORSENING POST OPERATIVE KNEE PAIN EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT KNEE). TREATMENTS: PHYSICAL THERAPY, MANIPULATION OF KNEE UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052580 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 9173962

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ATTUNE FEM NAR POR PS RT SZ 6| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS RP INSRT SZ6 5MM| ATTUNE RP TIB BASE SZ 4 POR| ATTUNE FEM NAR POR PS RT SZ 6| ATTUNE MEDIAL DOME PAT 35MM| ATTUNE PS RP INSRT SZ6 5MM| ATTUNE RP TIB BASE SZ 4 POR