BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9968441 · Received April 16, 2020

    Report

    Report Number
    1818910-2020-10865
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    January 1, 2019
    Report Date
    April 9, 2020
    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

    Narratives

    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. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE WAS IDENTIFIED. X RAYS REVIEWED. DISLOCATION OF THE HEAD / STEM ASSEMBLY FROM THE SHELL / LINER ASSEMBLY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED PART/LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS NOT IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED ¿CLINICAL OUTCOMES AND QUALITY OF LIFE AFTER TOTAL HIP ARTHROPLASTY IN ADULT PATIENTS WITH A HISTORY OF INFECTION OF THE HIP IN CHILDHOOD: A MID-TERM FOLLOW-UP STUDY¿, WRITTEN BY YUE LUO ET AL, PUBLISHED IN THE JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 2019, HTTPS://DOI.ORG/10.1186/S13018-019-1074-4, WAS REVIEWED. THE PURPOSE OF THE ARTICLE WAS TO ANALYZE RECURRENCE AND OTHER OUTCOMES IN PATIENTS WHO UNDERWENT PRIMARY CEMENTLESS THA MORE THAN 10 YEARS AFTER RESOLUTION OF HIP INFECTION. DEPUY PRODUCTS USED: PINNACLE ACETABULAR COMPONENT; S-ROM STEM; UNKNOWN DEPUY STEM. 105 CASES (108 HIPS) WITH OSTEOARTHRITIS SECONDARY TO HIP SEPTIC INFECTION WERE TREATED WITH CEMENTLESS TOTAL HIP REPLACEMENT. IN 90 HIPS, THE ACETABULAR COMPONENT WAS PRESS-FIT; IN THE REMAINING 11 HIPS, ONE OR TWO SCREWS WERE ADDED TO AUGMENT FIXATION. CERAMIC-ON-CERAMIC MATERIAL WAS USED IN 74 HIPS, WHILE METAL-ON-POLY MATERIAL WAS USED IN 27 HIPS. NO CEMENT WAS USED. ADVERSE EVENTS: FOUR PATIENTS EXPERIENCED A MODERATE POSTOPERATIVE LIMP WHICH WAS NOT TREATED. THE AUTHOR STATES SEVERE NONOPERATIVE LIMB PAIN CAUSED BY OSTEOARTHRITIS OF THE HIP MAY BE ONE OF THE CAUSES OF THE FOUR PATIENTS (FOUR HIPS) OF MODERATE LIMP. ONE PATIENT HAD PROGRESSIVE RADIOLUCENT LINES AROUND THE PROXIMAL FEMORAL STEM, WHICH LEADS TO PROGRESSIVE LOOSENING OF THE FEMORAL COMPONENT. REVISION SURGERY WAS PERFORMED AT 2.2 YEARS AFTER INITIAL THA. ONE PATIENT HAD LOOSENING OF THE ACETABULAR CUP AT POSTOPERATIVE 5.5 YEARS, AND THE ACETABULAR COMPONENT WAS REVISED. ASYMPTOMATIC HETEROTOPIC OSSIFICATION WAS IDENTIFIED VIA RADIOGRAPH IN FIVE HIPS. THERE WERE SEVEN CASES OF FEMORAL FRACTURE; TWO CASES OF PROXIMAL FEMUR AND FIVE CASES OF DISTAL FEMUR. ALL WERE TREATED WITH CERCLAGE WIRES AND HEALED UNEVENTFULLY. FOUR PATIENTS EXPERIENCED POSTOPERATIVE DISLOCATION ONCE. ONE WAS TREATED WITH CLOSED REDUCTION, WHILE THE OTHERS WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. THREE PATIENTS EXPERIENCED TRANSIENT SCIATIC NERVE PALSY WITH WEAK ANKLE DORSIFLEXION AND FOOT NUMBNESS. THEY WERE ALL TREATED WITH PRESCRIPTION DRUGS AND RETURNED TO NORMAL AFTER EIGHT MONTHS WITHOUT ANY SENSORY OR MOTOR DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433509 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention