BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK CEMENT GENTAMICIN

    MDR report key: 13666140 · Received March 4, 2022

    Report

    Report Number
    1818910-2022-04074
    Event Type
    Death
    Date Received
    March 4, 2022
    Date of Event
    December 31, 2020
    Report Date
    March 3, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MBB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DMF# - (B)(4), TRADE NAME GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE, DOSAGE FORM ¿ POWDER, STRENGTH 1.0G ACTIVE IN OUR CEMENTS. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    LITERATURE ARTICLE ENTITLED: ¿EXETER UNIVERSAL CEMENTED FEMORAL COMPONENT ¿ A 20-YEAR FOLLOW-UP STUDY FROM A DISTRICT GENERAL HOSPITAL¿, BY F. KHATUN, ET. AL., PUBLISHED BONE JOINT J 2020;102-B(10):1319¿1323, WAS REVIEWED. AUTHORS PRESENTED SURVIVAL, RADIOGRAPHIC, AND CLINICAL OUTCOME RESULTS OF A 225 TOTAL HIP COHORT AT 20 YEARS FOLLOW-UP. ALL PATIENTS HAD IMPLANTED THE SAME COMPETITOR BRAND CEMENTED STEM, USING DEPUY CMW 3 BONE CEMENT WITH GENTAMYCIN IN ALL BUT TWO OF THESE COMPETITOR STEMS (COMPETITOR BRAND CEMENT IN 2 CASES). THESE FEMORAL STEMS AND HEADS WERE PAIRED WITH EITHER 213 CEMENTED DEPUY ELITE OGEE ULTRA-HIGH MOLECULAR WEIGHT ALL POLYETHYLENE ACETABULAR CUP COMPONENTS, OR 12 CEMENTLESS COMPETITOR CUP AND LINER COMPONENTS. THE CEMENTED DEPUY CUPS ALL USED DEPUY CMW 3 BONE CEMENT WITH GENTAMYCIN. THE STUDY FOUND EXCELLENT LONG-TERM RESULTS AT TWENTY YEARS FOLLOW-UP. REGARDING COMPLICATIONS, AT 20 YEARS, 144 PATIENTS (AFFECTING 57 HIPS) OF THE TOTAL 207 PATIENTS HAD DIED. OF THESE, TWO PATIENTS DIED IN THE ACUTE POSTOPERATIVE PERIOD, THEIR DEATHS BEING DIRECTLY ATTRIBUTABLE TO THE SURGERY; ONE HAD A PULMONARY EMBOLUS AND THE OTHER HAD A PERIOPERATIVE MYOCARDIAL INFARCTION. THE REMAINING 142 DEMONSTRATED NO ASSOCIATION BETWEEN THEIR DEATHS AND THE IMPLANTS OR SURGICAL PROCEDURES. IN THE 42 SURVIVING HIPS AT TWENTY YEARS FOLLOW-UP, HETEROTOPIC OSSIFICATION WAS FOUND IN VARYING GRADES IN 31 PATIENTS. TOTAL HIP REVISIONS OCCURRED IN 16 HIPS: 3: FEMORAL OSTEOLYSIS AND ASEPTIC LOOSENING ¿ BOTH COMPONENTS REVISED . 1: FEMORAL PERIPROSTHETIC FEMUR FRACTURE ¿ FEMUR REVISED. 8: ACETABULAR OSTEOLYSIS AND ASEPTIC LOOSENING ¿ ACETABULUM ONLY REVISED . 2: ACETABULAR OSTEOLYSIS AND ASEPTIC LOOSENING IN BOTH COMPONENTS ¿ BOTH COMPONENTS REVISED. 1: INFECTION ¿ BOTH COMPONENTS REVISED. 1: INFECTION ¿EXCISION ARTHROPLASTY FOR FAILED 2-STAGE TREATMENT OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818844 UNK CEMENT GENTAMICIN BONE CEMENT MBB DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention