BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 14757365 · Received June 21, 2022

    Report

    Report Number
    1818910-2022-11384
    Event Type
    Injury
    Date Received
    June 21, 2022
    Report Date
    June 21, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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

    ARTICLE ENTITLED "TWO KINDS OF TOTAL HIP ARTHROPLASTY FOR THE TREATMENT OF ADULT UNILATERAL CROWE IV TYPE HIP DYSPLASIA" WRITTEN BY MEI XIAOLIANG, ZHANG ZHENXIANG, TONG JIAN, ZHU WEI, AND ZHAO JIANNING WAS REVIEWED. THE AIM OF THE STUDY WAS TO COMPARE THE CLINICAL EFFICACY OF TWO KINDS OF TOTAL HIP ARTHROPLASTY (THA) FOR THE TREATMENT OF ADULT CROWE IV TYPE HIP DYSPLASIA (DDH) WITHOUT OSTEOTOMY AND SUBTROCHANTERIC OSTEOTOMY. THIS STUDY RETROSPECTIVELY ANALYZED 35 ADULT PATIENTS WITH CROWE IV DDH WHO UNDERWENT THA FROM JANUARY 2014 TO OCTOBER 2017. THE PATIENTS WERE TREATED WITH BIOTYPE PROSTHESIS THROUGH POSTEROLATERAL APPROACH, IN WHICH COMMON BIOTYPE PROSTHESIS STEM (JOHNSON & JOHNSON, USA) WAS USED FOR THE FEMORAL SIDE IN NON-OSTEOTOMY GROUP, AND S-ROM GROUP MATCHING FEMORAL STEM (JOHNSON & JOHNSON, USA) WAS USED FOR THE FEMORAL SIDE IN SUBTROCHANTERIC OSTEOTOMY GROUP. NON-OSTEOTOMY GROUP HAD 2-3 SCREWS FOR ACETABULAR FIXATION. OSTEOTOMY GROUP HAD ONE HOLLOW SCREW. ADVERSE EVENTS: IN THE NON-OSTEOTOMY GROUP, THERE WAS 1 CASE OF SCIATIC NERVE TRACTION INJURY AND 1 CASE OF FEMORAL NEUROCUTANEOUS NERVE BRANCH INJURY AFTER SURGERY, WHICH RECOVERED SPONTANEOUSLY WITHOUT SEQUELAE. IN THE SUBTROCHANTERIC OSTEOTOMY GROUP, THERE WERE 3 CASES OF FEMORAL SPLIT FRACTURE, WHICH WERE FIXED WITH STEEL WIRE AND FOLLOWED BY BED REST FOR 3 MONTHS AND LATE AMBULATION. IN THE SUBTROCHANTERIC OSTEOTOMY GROUP 1 CASE OF HIP DISLOCATION OCCURRED IN THE SUBTROCHANTERIC OSTEOTOMY GROUP 1 WEEK AFTER SURGERY, AND NO RE-DISLOCATION OCCURRED AFTER CLOSED REDUCTION (AGE 46-YEAR-OLD MALE). LEG LENGTH DISCREPANCY WAS NOTED IN BOTH GROUPS. NO INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158942 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention