BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM F

    MDR report key: 11495302 · Received March 16, 2021

    Report

    Report Number
    0001822565-2021-00730
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 24, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQI
    UDI-DI
    00889024519916
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED.   REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING.   A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.   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 DEVICES: BIOMET TPRLC 133 T1 PPS HO 12X144MM, CAT#: 51-104120, LOT#: 6786095; BIOMET CER BIOLOXD MOD HD 36MM +6 NK, CAT#: 12-115123, LOT#: 2972001; BIOMET G7 PPS LTD ACET SHELL 56F, CAT#: 10000665, LOT#: 6807678. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH LATER DUE TO LEG LENGTH DISCREPANCY. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED. 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
    393831 G7 VIT E NEUTRAL LNR 36MM F PROSTHESIS, HIP OQI ZIMMER BIOMET, INC. N/A 64952318 00889024519916

    Patients

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