BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 7521735 · Received May 17, 2018

    Report

    Report Number
    1818910-2018-59833
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    October 9, 2017
    Report Date
    July 17, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295174288
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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: 1 UNRELATED NON CONFORMANCE ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING. TOTAL FOR LOT NUMBER: 1 ((B)(4)). COMPLAINTS RECEIVED BY (B)(4) IN THE LAST 12 MONTHS FOR THIS ISSUE: BY PRODUCT CODE: 45. BY PRODUCT FAMILY: 158 (47X SMARTSET GHV, 111C SMARTSET GMV).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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: 1 UNRELATED NON CONFORMANCE ON THIS BATCH. MICRO AND STERILITY TESTS PASSED COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING. TOTAL FOR LOT NUMBER: 1 (PC-(B)(4)) COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: (B)(4) BY PRODUCT FAMILY: (B)(4)(47X SMARTSET GHV, 111C SMARTSET GMV).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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: ONE UNRELATED NON CONFORMANCE ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. COMPLAINTS DATABASE SEARCHED: A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 1 ADDITIONAL REPORT RELATED TO IMPLANT LOOSENING. TOTAL FOR LOT NUMBER: 1 (B)(4). COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: 45. BY PRODUCT FAMILY: 158 (47X SMARTSET GHV, 111C SMARTSET GMV). (B)(4) USED TO CAPTURE THE SURGICAL INTERVENTION. 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

    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

    ON (B)(6) 2018 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017 TO ADDRESS PAIN, COLLAPSE OF MEDIAL TIBIAL PLATEAU WITH RESULTANT VARUS ALIGNMENT OF THE TIBIAL COMPONENT. THE TIBIAL TRAY WAS NOTED TO BE LOOSE AT UNKNOWN INTERFACE. DEPUY CEMENT WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364765 SMARTSET GHV GENTAMICIN 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 5450-35-500 8419941 10603295174288

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention