BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEXLOC LINER

    MDR report key: 6085047 · Received November 8, 2016

    Report

    Report Number
    0001825034-2016-04506
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    March 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OQG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. AGE OR DATE OF BIRTH - NI, WEIGHT - NI, DATE OF DEATH - NI, DATE OF EVENT - NI, DEVICE CODE - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, (B)(6), MANUFACTURE DATE ¿ NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION PREVIOUSLY REPORTED. IF ANOTHER FOLLOW-UP IS NEEDED ANOTHER REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "NO IMPROVEMENT IN LONG-TERM WEAR AND REVISION RATES WITH THE SECOND-GENERATION BIOMET CUP (RINGLOC) IN YOUNG PATIENTS" WHICH AIMED TO EXAMINE THE CLINICAL RESULTS FOLLOWING TOTAL HIP ARTHROPLASTY IN A STUDY OF 111 PATIENTS YOUNGER THAN 55 YEARS THAT EXPERIENCED POSSIBLE POOR PERFORMANCE OF CEMENTLESS TITANIUM ACETABULAR COMPONENTS USING THE HEXLOC SYSTEM AND MALLORY HEAD ACETABULAR COMPONENTS MANUFACTURED BY BIOMET; AND TO INVESTIGATE THE WHETHER RESULTS COULD BE IMPROVED WITH A SECOND-GENERATION DESIGN, THE RINGLOC. TWENTY-TWO 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 REVISIONS DUE TO LINER WEAR AND/OR ACETABULAR LOOSENING. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, 22 PATIENTS UNDERWENT TOTAL HIP REVISION PROCEDURES DUE TO LINER WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENTS IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738638 UNKNOWN HEXLOC LINER HIP PROSTHESIS OQG BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R