BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 11057750 · Received December 22, 2020

    Report

    Report Number
    1818910-2020-27553
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 10, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS 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 : 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 · 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

    LITERATURE ARTICLE ENTITLED, ¿MINIMUM 5 YEAR FOLLOW-UP OF CLINICAL AND RADIOGRAPHIC RESULTS OF CEMENTED ACETABULAR COMPONENTS WITH AN INTERFACE BIOACTIVE BONE CEMENT TECHNIQUE IN PRIMARY CEMENTED TOTAL HIP ARTHROPLASTY¿ BY SHUICHI MIYAMOTO, ET AL, PUBLISHED BY ARCHIVED OF ORTHOPAEDIC AND TRAUMA SURGERY (2020), HTTPS://DOI.ORG/10.1007/S00402-020-03638-6, 11 PAGES, WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE MIDTERM CLINICAL AND RADIOLOGICAL RESULTS OF FIXING THE ACETABULAR COMPONENT USING THE INTERFACE BIOACTIVE BONE CEMENT TECHNIQUE IN PRIMARY CEMENTED THA FOR 193 HIPS IMPLANTED USING A VARIETY OF SURGICAL APPROACHES AND DEVICES. ALL CEMENT USED WAS ANTIBIOTIC LOADED WITH 0.5G CEFAZOLIN PER 40G BONE CEMENT. THE AUTHORS USED BOTH DEPUY AND COMPETITOR CEMENT AND DEVICES AND ALLOGRAFT. THE RESULTS DID NOT SPECIFY MANUFACTURER. THE ACTUAL NUMBER OF DEPUY PRODUCTS ASSOCIATED WITH THE ADVERSE EVENTS IS UNKNOWN. DEPUY COMPONENTS USED IN THE STUDY: 35 CHARNLEY ELITE PLUS OGEE HIPS INCLUDING A CEMENTED POLYETHYLENE CUP, FEMORAL STEM, AND FEMORAL HEAD. 19 CHARNLEY OGEE HIPS INCLUDING A CEMENTED POLYETHYLENE CUP, FEMORAL STEM, AND FEMORAL HEAD. DEPUY ENDURANCE ANTIBIOTIC LOADED CEMENT WAS UTILIZED IN 45 HIPS. RESULTS: 1 REVISION FOR DEEP INFECTION OF THE FEMORAL COMPONENT AT 9 YEARS. 1 REVISION FOR DEEP INFECTION AND OSTEOLYSIS OF THE ACETABULAR AND FEMORAL COMPONENTS. THE AUTHORS NOTE THIS PATIENT HAD NOTED RADIOLUCENT LINES BUT NO INTRAOPERATIVE INDICATION OF ACETABULAR OR FEMORAL COMPONENT OF LOOSENING. THE AUTHORS DIRECTLY ATTRIBUTED THE OSTEOLYSIS TO THE DEEP INFECTION. 1 FEMORAL REVISION DUE TO A PERIPROSTHETIC FEMORAL FRACTURE AT 5 YEARS. 2 CUP REVISION TO TREAT CUP MIGRATION AT 1 YEAR AND 7 MONTHS, RESPECTIVELY. RADIOGRAPHIC RESULTS: 47 PATIENTS, WHO WERE NOT REVISED, HAD EVIDENCE OF RADIOLUCENT LINES IN AT LEAST ONE ZONE- NO TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518809 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention