BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS

    MDR report key: 16067920 · Received December 29, 2022

    Report

    Report Number
    0001822565-2022-03566
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 6, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024151345
    PMA / PMN Number
    K200823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 11-165236 LOT 497960 RINGLOC BI-POLAR ZIMMER CAT# 192412 LOT 000260 ECHO POR FMRL. CAT # 00625006520 LOT J7360863 BONE SCR. CAT # 00625006520 LOT J7373554 BONE SCR. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-03589. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 RETURNED PRODUCT IDENTIFIED LINER WAS RETURNED PARTIALLY SEATED IN THE SHELL. DEFORMATION DAMAGE WAS NOTED AROUND THE MIDDLE OF THE THREE CLUSTER HOLES OF THE SHELL, ALONG WITH NICKS AND SCRATCHES. THE DEFORMATION EXTENDS INTO THE MACHINED LOCKING GROOVE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 LINER WOULD NOT FULLY SEAT WITH THE CUP. THE PATIENT'S BONE QUALITY WAS TOO POOR; THEREFORE, THE SURGERY WAS COMPLETED WITH BIPOLAR DEVICES. THERE WAS NO CONSEQUENCES OR IMPACT 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
    2238956 50MM O.D. SIZE HH POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH HH LINERS PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 65540798 00889024151345

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female SEE H10 NARRATIVE.