BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REGEREX ACETABULAR CUP COMPONENT

    MDR report key: 6081137 · Received November 7, 2016

    Report

    Report Number
    0001825034-2016-04459
    Event Type
    Injury
    Date Received
    November 7, 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
    DA
    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. (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, ¿MULTICENTER EVALUATION OF IN VIVO WEAR OF VITAMIN E STABILIZED HIGHLY CROSS-LINKED POLYETHYLENE AND ACETABULAR CUP STABILITY¿ WHICH AIMED TO EXAMINE THE CLINICAL RESULTS FOLLOWING TOTAL HIP ARTHROPLASTY FOR 204 PATIENTS USING THE REGENEREX OR RINGLOC ACETABULAR COMPONENT, THE E1 OR ARCOMXL POLYETHYLENE TIBIAL BEARING, A STEM AND A COBALT CHROME OR CERAMIC FEMORAL HEAD MANUFACTURED BY BIOMET; AND TO INVESTIGATE BEARING WEAR AND ACETABULAR CUP STABILITY POST-OPERATIVELY. AN UNKNOWN NUMBER OF PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT HIP ARTHROPLASTIES ON UNKNOWN DATES. PATIENT FOLLOW-UP RESULTS PROVIDED INDICATE THAT THE REGENEREX CUPS AT THE (B)(6) HOSPITAL IN DENMARK ARE SETTLING SIGNIFICANTLY MORE THAN WITH THE ACETABULAR CUPS AT (B)(6) HOSPITAL IN (B)(6) AND MASSACHUSETTS GENERAL HOSPITAL IN THE UNITED STATES. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732044 UNKNOWN REGEREX ACETABULAR CUP COMPONENT HIP PROSTHESIS JDI BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other