BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 17165147 · Received June 20, 2023

    Report

    Report Number
    0001825034-2023-01375
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 17, 2023
    Report Date
    August 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355899
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 00879000703, MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH, CAT#: 574202050, LOT#: 3142207, AVENIR CMPL HA HO COL SIZE 5, CAT#: 00877502802, LOT#: 3141226, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, A 28/0, TAPER 12/14, CAT#: 00625006525, LOT#: 65537993, BONE SCR 6.5X25 SELF-TAP, CAT#: 110024464, LOT#: 65887407, G7 DUAL MOBILITY LINER 44MM FJ, CAT#: 110031012, LOT#: 65851661, VIVACIT-E DM BEARING 28X44MM. THE CUSTOMER HAS INDICATED, THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MALPOSITION OF THE SINGLE ACETABULAR FIXATION SCREW AS NOTED. THE SINGLE ACETABULAR SCREW PASSES ENTIRELY THROUGH THE CUP APERTURE AND PROVIDES NO CUP FIXATION. 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

    IT WAS REPORTED, THAT A TRILOGY SCREW HAS GONE ALL THE WAY THROUGH THE OSSEOTI CUP. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526511 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65703642 00887868355899

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10 NARRATIVE