BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 7107691 · Received December 12, 2017

    Report

    Report Number
    1818910-2017-51278
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: ( IT SHOULD BE BLANK SINCE THE PRODUCT WAS NOT RETURNED). PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH ON THE PROVIDED SMARTSET GHV GENTAMICIN 40G (PRODUCT 545035500, LOT NUMBER 7961077) FOUND ADDITIONAL REPORTS AND A DHR REVIEW WAS CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. DEVICE HISTORY LOT: DEVICE HISTORY REVIEWED: NO NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND ADDITIONAL REPORTS, HOWEVER ONLY ONE OTHER INCIDENT RELATED TO PAIN AND LOOSENING. TOTAL FOR LOT NUMBER: 2 ((B)(4)) COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 5. BY PRODUCT FAMILY: 13 (7X SMARTSET GHV, 8X SMARTSET GMV). DEVICE HISTORY LOT: NULL. DEVICE HISTORY REVIEW: NULL. 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

    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

    PATIENT WAS REVISED TO ADDRESS RAPID INCREASE IN PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS FROM DEPUY. IT WAS ALSO REPORTED THAT X-RAYS SHOWS A LARGE ANTERIOR MEDIAL DEFECT ALL THE WAY THROUGH THE BONE. AP X-RAY SHOWS MEDIAL COLLAPSE OF TIBIA. SURGEON FELT THIS WAS A CASE OF ASEPTIC LOOSENING OF TIBIA WITH ADDITIONAL FACTORS OF OBESITY AND POSSIBLE FUNGAL INFECTION. THE LATER WASN¿T CONFIRMED BY PATHOLOGY AT THIS TIME. THE SURGEON WAS CONCERNED WITH THE AMOUNT OF SCRATCHING, PITTING AND WEAR THAT THEY POLY COMPONENTS EXHIBITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886969 SMARTSET GHV GENTAMICIN 40G BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910 7961077 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention