BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM I.D. 7MM OFFSET SIZE HH LINER USE WITH 50MM O.D. SIZE HH SHELL

    MDR report key: 17660565 · Received August 31, 2023

    Report

    Report Number
    0001822565-2023-02333
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    August 2, 2023
    Report Date
    October 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024150447
    PMA / PMN Number
    K200823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877503203, LOT# 3102206, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14. CAT# 00625006525 LOT# J7283511 BONE SCR 6.5X25 SELF-TAP. CAT# 00875705001 LOT# 65702740 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES. SHELL USE WITH HH LINERS. G2: FOREIGN: JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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 THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 MONTHS LATER DUE TO DISLOCATION. 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
    1602397 32MM I.D. 7MM OFFSET SIZE HH LINER USE WITH 50MM O.D. SIZE HH SHELL PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 64467365 00889024150447

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R