BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 LONGEVITY 10DEG LNR 32MM C

    MDR report key: 12682946 · Received October 22, 2021

    Report

    Report Number
    0001822565-2021-02962
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518964
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.THE FOLLOWING SECTIONS WERE UPDATED/CORRECTEDUPDATED: G3; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED OF THE LINER; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED.REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT.MEDICAL RECORDS WERE NOT PROVIDED.A DEFINITIVE ROOT CAUSE CANNOT 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 PRODUCTS: ITEM NUMBER 110010242 ITEM NAME G7 OSSEOTI 3 HOLE SHELL48MM C LOT # 7075111. ITEM NUMBER 010001000 ITEM NAME G7 SCREW 6.5MM X 35MM LOT # 7053140. ITEM NUMBER 20113203 ITEM NAME G7 LONGEVITY 10DEG LNR32MM C LOT # 64610579. ITEM NUMBER 00-8777-032-02 ITEM NAME BIOLOX DELTA OPTION FEMHEAD, 32MM, +0MM LOT # 3007576. ITEM NUMBER 01.00561.314 ITEM NAME WAGNER CONE 135 DEG 14MM LOT # 2910801. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT INTO CORRECT SIZE CUP. SECOND LINER WAS OPENED IDENTICAL TO THE FIRST THAT WAS ABLE TO SEAT ON FIRST TRY. 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
    1579936 G7 LONGEVITY 10DEG LNR 32MM C PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64626699 00889024518964

    Patients

    Seq Age Sex Outcome Treatment
    1