BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 5906349 · Received August 26, 2016

    Report

    Report Number
    0001825034-2016-03312
    Event Type
    Injury
    Date Received
    August 26, 2016
    Report Date
    July 27, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. DEVICE CODE - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY STEPHEN E. GRAVES, ALASTAIR ROTHWELL, KEITH TUCKER, JOSHUA J. JACOBS AND ART SEDRAKYAN. MANUFACTURE DATE ¿ UNKNOWN. DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, " A MULTINATIONAL ASSESSMENT OF MOM BEARINGS IN HIP REPLACEMENT" WHICH AIMED TO EXAMINE THE INCREASING EVIDENCE THAT MANY METAL-ON-METAL (METAL ON METAL) BEARINGS, WHEN USED WITH LARGE FEMORAL HEADS IN CONVENTIONAL HIP REPLACEMENT AND SOME RESURFACING PROSTHESES, ARE ASSOCIATED WITH INCREASED RATES OF REVISION ARTHROPLASTY. REGISTRIES ARE THE MAIN SOURCES OF DATA ON METAL ON METAL PROSTHESES. AT THE RECENT INTERNATIONAL CONSORTIUM OF ORTHOPAEDIC REGISTRIES (ICOR) MEETING, DATA WAS PRESENTED FROM THE (B)(4). ALL REGISTRIES REPORTED AN INCREASED RATE OF REVISION FOR LARGE FEMORAL HEAD METAL ON METAL PROSTHESES WHEN PROSTHESES WERE AGGREGATED COMPARED WITH THE AGGREGATED DATA OF HIP PROSTHESES WITH OTHER BEARING SURFACES. THERE WAS ALSO EVIDENCE, HOWEVER, THAT THE OUTCOME VARIED, DEPENDING ON THE TYPE OF PROSTHESES USED, IN BOTH LARGE FEMORAL HEAD METAL ON METAL CONVENTIONAL HIP REPLACEMENT AS WELL AS RESURFACING HIP REPLACEMENT. PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENTS HAD AN AVERAGE REVISION RATE AT THREE YEARS POST-OP. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENTS HAD AN AVERAGE REVISION RATE OF 4.0 AT THREE YEARS POST-OP. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561106 UNKNOWN M2A HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R