BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ARCOM CONVENTIONAL POLYETHYLENE LINER

    MDR report key: 6092977 · Received November 10, 2016

    Report

    Report Number
    0001825034-2016-04622
    Event Type
    Death
    Date Received
    November 10, 2016
    Report Date
    June 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY MANABU TSUKAMOTO, HIDEO OHNISHI, TOSHIHARU MORI, MAKOTO KAWASAKI, SOSHI UCHIDA AND AKINORI SAKAI (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, ¿FIFTEEN-YEAR COMPARISON OF WEAR AND OSTEOLYSIS ANALYSIS FOR CROSS-LINKED OR CONVENTIONAL POLYETHYLENE IN CEMENTLESS TOTAL HIP ARTHROPLASTY FOR HIP DYSPLASIA ¿ A RETROSPECTIVE COHORT STUDY¿ WHICH AIMED TO EXECUTE A 15-YEAR RETROSPECTIVE COHORT STUDY ON CEMENTLESS TOTAL HIP ARTHROPLASTY PERFORMED IN PATIENTS WITH DEVELOPMENTAL HIP DYSPLASIA TO MEASURE THE DIFFERENCES IN POLYETHYLENE WEAR RATES AND THE PRESENCE OF OSTEOLYSIS USING CROSS-LINKED POLYETHYLENE ARCOM AND UNKNOWN BIOMET CONVENTIONAL POLYETHYLENE LINERS AND THE MALLORY-HEAD CEMENTLESS SYSTEM MANUFACTURED BY BIOMET; AND TO INVESTIGATE WHETHER CROSS-LINKED POLYETHYLENE AND CONVENTIONAL POLYETHYLENE LINERS. TWO PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT HIP ARTHROPLASTIES UNKNOWN DATES. PATIENT FOLLOW-UP RESULTS PROVIDED INDICATE THAT THE PATIENTS WERE DECEASED AT THE TIME OF THE STUDY IN THE CONVENTIONAL POLYETHYLENE GROUP. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743517 UNKNOWN ARCOM CONVENTIONAL POLYETHYLENE LINER HIP PROSTHESIS JDI BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death