BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 44MM F

    MDR report key: 9981010 · Received April 21, 2020

    Report

    Report Number
    0001825034-2020-01754
    Event Type
    Injury
    Date Received
    April 21, 2020
    Date of Event
    April 7, 2020
    Report Date
    July 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    UDI-DI
    00880304703520
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  THE FOLLOWING SECTIONS WERE  UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS PROVIDED. REVIEW OF THE PHOTOGRAPHS SHOW THE DEVICES SEPARATED, WITH BLOOD STAINS.DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP). IMPRESSIONS: 1. LEFT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE LEFT ACETABULAR CUP. NO RADIOLUCENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: EP-200150 LOT NUMBER: 935390 BRAND NAME: ACT ARTIC E1 HIP BRG, CATALOG NUMBER:31-323240 LOT NUMBER: 026700 BRAND NAME: 3.2MMX40MM RNGLC, CATALOG NUMBER:110010266 LOT NUMBER:6680970 BRAND NAME: G7 ACETABULAR SHELL. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01755. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 2 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445079 G7 DUAL MOBILITY LINER 44MM F PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 372990 00880304703520

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R SEE H10 NARRATIVE.