BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCR 6.5X25 SELF-TAP

    MDR report key: 17151113 · Received June 19, 2023

    Report

    Report Number
    0002648920-2023-00125
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119819
    PMA / PMN Number
    K934765
    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 LOT# UNK 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, ø 28/0, TAPER 12/14 CAT# 110010245 LOT# 65703642 G7 OSSEOTI 4 HOLE SHELL 54MM F CAT# 110024464 LOT# 65887407 G7 DUAL MOBILITY LINER 44MM FJ CAT# 110031012 LOT# 65851661 VIVACIT-E DM BEARING 28X44MM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837694 BONE SCR 6.5X25 SELF-TAP PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 65537993 00889024119819

    Patients

    Seq Age Sex Outcome Treatment
    1 Male