BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MALLORY-HEAD ACETABULAR COMPONENT

    MDR report key: 6090489 · Received November 9, 2016

    Report

    Report Number
    0001825034-2016-04602
    Event Type
    Injury
    Date Received
    November 9, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDG
    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 ARTICLE WAS WRITTEN BY WEIRD P. ZIJLSTRA, INGE VAN DEN AKKER-SCHEEK, MARK J. M. ZEE AND JOS J.A.M. VAN RAAY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "NO CLINICAL DIFFERENCE BETWEEN LARGE METAL-ON-METAL TOTAL HIP ARTHROPLASTY AND 28-MM-HEAD TOTAL HIP ARTHROPLASTY?" WHICH AIMED TO TEST THE CLAIM OF GREATER RANGE OF MOTION (ROM) WITH LARGE FEMORAL HEAD METAL-ON-METAL TOTAL HIP ARTHROPLASTY USING MMAGNUM AND MALLORY-HEAD ACETABULAR COMPONENTS WITH ARCOM LINERS MANUFACTURED BY BIOMET; AND TO INVESTIGATE WHETHER LARGE FEMORAL HEAD METAL-ON-METAL TOTAL HIP TOTAL ARTHROPLASTY HAS GREATER ROM AT ONE YEAR POSTOPERATIVELY COMPARED TO 28-MM METAL-ON-POLYETHYLENE. TWO PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT HIP ARTHROPLASTIES ON UNKNOWN DATES. PATIENT FOLLOW-UP RESULTS PROVIDED INDICATE THAT THE PATIENTS EXPERIENCED GRADE 2 PERIARTICULAR OSSIFICATION POST-OPERATIVELY USING METAL-ON-POLYETHYLENE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740871 UNKNOWN MALLORY-HEAD ACETABULAR COMPONENT HIP PROSTHESIS JDG BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other