BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET ACETABULAR COMPONENT

    MDR report key: 6092980 · Received November 10, 2016

    Report

    Report Number
    0001825034-2016-04628
    Event Type
    Injury
    Date Received
    November 10, 2016
    Report Date
    October 11, 2016
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. INITIAL REPORTER  THE ARTICLE WAS WRITTEN BY NANNA H. SILLESEN, MERIDITH E. GREENE, AUDREY K. NEVERGALL, YOUNG-MIN KWON, CHARLES BRAGDON, ANDERS TROELSEN, JAMES I. HUDDLESTON, EDUARDO GARCIA-CIMBRELO AND HENRIK MALCHAU INVOLVING THE HOSPITALS MASSACHUSETTS GENERAL HOSPITAL, MASSACHUSETTS, USA, COPENHAGEN UNIVERSITY, HVIDOVRE, DENMARK, STANFORD UNIVERSITY, CALIFORNIA, USA AND HOSPITAL LA PAZ, MADRID, SPAIN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, EARLY FOLLOW-UP OF A LONG-TERM REGISTRY-BASED MULTICENTER TOTAL HIP REPLACEMENT OUTCOME STUDY: VITAMIN E DOPED POLYETHYLENE LINER AND POROUS-TITANIUM COATED ACETABULAR SHELLS. WHICH AIMED TO EVALUATE THE CLINICAL AND RADIOGRAPHIC RESULTS OF 977 PATIENTS AFTER TOTAL HIP ARTHROPLASTY USING REGENEREX OR RINGLOC ACETABULAR COMPONENTS WITH EITHER AN E1 OR ARCOMXL POLYETHYLENE LINERS MANUFACTURED BY BIOMET; AND TO MONITOR VITAMIN E DOPED POLYETHYLENE LINERS AND POROUS TITANIUM CONSTRUCT ACETABULAR SHELLS COMPARED TO UN-DOPED MEDIUM CROSS-LINKED POLYETHYLENE LINERS AND PLASMA SPRAYED SHELLS IN PATIENTS. FOUR PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT HIP ARTHROPLASTIES ON UNKNOWN DATES. PATIENT FOLLOW-UP RESULTS PROVIDED INDICATE THAT THE PATIENTS UNDERWENT HIP ARTHROPLASTY REVISION DUE TO PERIPROSTHETIC FRACTURE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745864 UNKNOWN BIOMET ACETABULAR COMPONENT HIP PROSTHESIS JDI BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R