BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 15041742 · Received July 18, 2022

    Report

    Report Number
    1818910-2022-13239
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 13, 2021
    Report Date
    July 18, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). LITERATURE IS A VALUABLE SOURCE OF INFORMATION. HOWEVER, IT HAS LIMITATIONS, INCLUDING NONSPECIFIC AND INDETERMINATE INFORMATION ABOUT EACH ADVERSE EVENT. THERE IS INSUFFICIENT INFORMATION WITHIN THE TEXT OF THIS ARTICLE TO DETERMINE ADVERSE EVENT ACCORDING TO DEVICE MANUFACTURER. THE ACTUAL NUMBER OF DEPUY PRODUCTS THAT MAY BE ASSOCIATED WITH EACH REPORTED ADVERSE EVENT IS UNKNOWN. WE WILL BE REPORTING THE REVISION, BUT NOT CODING FOR THE SPECIFIC HARMS LISTED AS WE DO NOT KNOW WHICH HARMS WERE WITH DEPUY PRODUCTS. THE HARMS LISTED WERE: INFECTION, LOOSENING, BONE FRACTURE, DISLOCATION, ALTR, AND PAIN WERE LISTED AS THE CAUSES OF REVISION FOR THESE 18 PATIENTS. THE STUDY WAS LOOKING AT SURFACE WEAR ON TRUNNIONS AND CORROSION. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 ¿A COMPARISON OF METAL/METAL AND CERAMIC/METAL TAPER-TRUNNION MODULAR CONNECTIONS IN EXPLANTED TOTAL HIP REPLACEMENTS "WRITTEN BY CADEL ES, TOPOLESKI LDT, VESNOVSKY O, ANDERSON CR, HOPPER RH JR, ENGH CA JR, DI PRIMA MA PUBLISHED BY J BIOMED MATER RES B APPL BIOMATER. 2022 JAN;110(1):135-143. DOI: 10.1002/JBM.B.34897 ON 23 JUNE 2021 WAS REVIEWED. WHILE METAL/METAL (M/M) MODULAR TAPER-TRUNNION CONNECTIONS EXHIBIT MORE WEAR/CORROSION THAN CERAMIC/METAL (C/M) MODULAR TAPER-TRUNNION CONNECTIONS, DAMAGE IS PRESENT IN BOTH, REGARDLESS OF MATERIAL. THIS STUDY USED A COMBINATION OF ASSESSMENT TECHNIQUES INCLUDING CLINICAL DATA, VISUAL SCORING ASSESSMENT, OPTICAL IMAGING, PROFILOMETRY, AND X-RAY PHOTOELECTRON MICROSCOPY (XPS), TO INVESTIGATE WEAR MECHANISMS AND DAMAGE FEATURES AT THE MODULAR TAPER-TRUNNION CONNECTION OF 10 M/M AND 8 C/M EXPLANTED THAS. NO CORRELATION WAS FOUND BETWEEN ANY DEMOGRAPHIC VARIABLE AND CORROSION WEAR AND ASSESSMENT SCORES. ALL ASSESSMENT TECHNIQUES DEMONSTRATED THAT THE STEM TRUNNIONS HAD MORE DAMAGE THAN HEAD TAPERS FOR BOTH EXPLANT GROUPS AND AGREED THAT C/M EXPLANTS HAD LESS CORROSION AND WEAR COMPARED TO M/M EXPLANTS. THESE RESULTS INDICATE THAT TAPER-TRUNNION DAMAGE IS MORE PREVALENT FOR M/M EXPLANTS, BUT C/M EXPLANTS ARE STILL SUSCEPTIBLE TO DAMAGE. MORE COMPREHENSIVE ANALYSIS OF DAMAGE IS NECESSARY TO BETTER UNDERSTAND THE ORIGINS OF TAPER-TRUNNION DAMAGE. OF THE 18 STUDIED EXPLANTS, 10 WERE DEPUY PINNACLE SYSTEMS (5 PRODIGY STEMS, 3 AML STEMS, 1 CORAIL STEM, AND 1 TRI-LOCK STEM), 2 WERE DEPUY DURALOC WITH AML STEMS. THERE WERE 6 COMPETITOR EXPLANTS STUDIED. INFECTION, LOOSENING, BONE FRACTURE, DISLOCATION, ALTR, AND PAIN WERE LISTED AS THE CAUSES OF REVISION FOR THESE 18 PATIENTS. THE STUDY WAS LOOKING AT SURFACE WEAR ON TRUNNIONS AND CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2893298 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention