BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TRABECULAR METAL 58MM O.D. SIZE LL POROUS UNCEMENTED

    MDR report key: 19475386 · Received June 6, 2024

    Report

    Report Number
    0001822565-2024-01908
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 27, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024151468
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00625006530 LOT# 63535924 BONE SCR 6.5X30 SELF-TAP. CAT# 00625006540 LOT# 63214016 BONE SCR 6.5X40 SELF-TAP. CAT# 00877501336 LOT# 2738375 BIOLOX® DELTA CERAMIC TAPER LINER, SIZE LL / 36 I.D. FOR USE WITH 58 MM O.D. SIZE LL SHELL. CAT# 11-300816 LOT# 124690 ARCOS 16X150MM SPL TPR DIST. CAT# 11-301304 LOT# 213170 ARCOS CON SZ D STD 60MM. CAT# 650-0661 LOT# 2017050061 DELTA CERAMIC FEM HD 36/0MM. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. 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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED LINER AND HEAD. PICTURES WERE NOT PROVIDED OF THE EXPLANTED SHELL. REVIEW OF THE DEVICE HISTORY RECORDS 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: ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY. THE PROVIDED X-RAY WAS UNDATED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE POSITIONING OF THE IMPLANTS IS SURGEON DISCRETION, AND IT IS UNKNOWN IF THE IMPLANT MAY HAVE MOVED OR WAS PLACED IN A WAY THAT WAS NOT ALIGNED. 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 THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 7 YEARS LATER DUE TO POOR ALIGNMENT OF THE ACETABULAR COMPONENT. THERE WAS REPRODUCIBLE AUDIBLE SQUEAKING AND CREPITUS BY THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE.

    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
    2789 CONTINUUM TRABECULAR METAL 58MM O.D. SIZE LL POROUS UNCEMENTED PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 63640013 00889024151468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE