BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM I.D. SIZE HH ELEVATED RIM LINER USE WITH 50MM O.D. SIZE HH SHELL

    MDR report key: 16067907 · Received December 29, 2022

    Report

    Report Number
    0001822565-2022-03589
    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
    LPH
    UDI-DI
    00889024149694
    PMA / PMN Number
    K151448
    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

    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. LINER SHOWS DAMAGE TO THE LOCKING FEATURE AND ANTI-ROTATION SCALLOPS. 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.

    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: 0001822565-2022-03566. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825279 32MM I.D. SIZE HH ELEVATED RIM LINER USE WITH 50MM O.D. SIZE HH SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65560108 00889024149694

    Patients

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