BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH

    MDR report key: 18255966 · Received December 4, 2023

    Report

    Report Number
    0001822565-2023-03388
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    October 24, 2023
    Report Date
    February 15, 2024
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00-6202-060-20, ITEM NAME: TM ACET SHELL 60MM MULTI, LOT# 63307782. G2: FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565 - 2023 - 03389. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 G3 G6 H2 H6 H10 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED HEX SHOWS NICKS AND GOUGES FROM USE. OUTER HEAD DIAMETER HAS A LIP FORMED FROM SCREW PENETRATION THROUGH THE SHELL CAUSING DEFORMATION. DISTAL THREADS AND TAPER BELOW HEAD SHOW WITNESS MARKS FROM INSERTION. THE CUP WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS 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

    IT WAS REPORTED THAT DURING A PROCEDURE THE SCREW PENETRATED THE SCREW HOLE. THE HEAD SECTION OF THE SCREW WAS DEFORMED. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504397 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A J7358568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose PLEASE SEE H10.