BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCR 6.5X25 SELF-TAP

    MDR report key: 17059151 · Received June 5, 2023

    Report

    Report Number
    0001822565-2023-01478
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    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). D10: 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. 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. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRILOGY SCREW HAS GONE ALL THE WAY THROUGH AN 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
    31191 BONE SCR 6.5X25 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65537993

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10 NARRATIVE.