BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 66MM I

    MDR report key: 8653353 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02359
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    April 25, 2019
    Report Date
    September 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET BIOLOX HEAD CAT#12-115109 LOT#2886313. BIOMET BEARING CAT#EP-200160 LOT#211710. BIOMET LINER CAT#110024467 LOT#058910. BIOMET STEM CAT#11-301300 LOT#946930. BIOMET TAPER CAT#11-300920 LOT#013480. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02358 0001825034 - 2019 - 02361

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A CLOSED REDUCTION OF A DISLOCATED RIGHT HIP APPROXIMATELY 1 YEAR POST IMPLANTATION. IT WAS FURTHER REPORTED THAT DURING THE REDUCTION, THE G7 BEARING DISASSOCIATED FROM THE BIOLOX HEAD. THIS LED TO A SECOND REVISION OF THE RIGHT HIP. IT WAS NOTED ESTIMATED BLOOD LOSS OF 100ML, SUBFASCIAL ADHESIONS NOTED DUE TO PREVIOUS INCISIONS, REDDISH SYNOVIAL FLUID NOTED (UNREMARKABLE), ANTERIOR OSTEOPHYTES NOTED AROUND THE ACETABULUM, WELL-FIXED ACETABULUM AND FEMORAL STEM, ADDUCTOR TENOTOMY PERFORMED DUE TO LIMITED RANGE OF MOTION PER PATIENT ANATOMY, NO INTRAOP COMPLICATIONS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447271 G7 OSSEOTI MULTIHOLE 66MM I PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3983154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other