BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM I.D. SIZE D HIGH WALL LINER

    MDR report key: 13966353 · Received March 31, 2022

    Report

    Report Number
    0001822565-2022-00894
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 15, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520424
    PMA / PMN Number
    K190660
    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). CONCOMITANT MEDICAL PRODUCTS: 00771300600 FEMORAL STEM SIZE 6 65079899. 00877503202 CERAMIC FEMORAL HEAD 3087336. 00784801200 MODULAR NECK E 12/14 TAPER 65226224. 110010263 G7 OSSEOTI MULTIHOLE 50MM 7150218. REPORT SOURCE: FOREIGN: (B)(6). 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

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NICKS AND SCRATCHES FROM IMPLANT AND EXPLANT. ANTI ROTATION SCALLOPS AND LOCKING FEATURE SHOWS GOUGES, INDENTATIONS, AND DEFORMATION. NO OTHER DAMAGE WAS NOTED. ROOT CAUSE REMAINS UNCHANGED FROM PREVIOUS INVESTIGATION. 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 REPLACEMENT SURGERY. AT THE END OF THE SURGERY, RADIOGRAPHIC CONFIRMATION WAS PERFORMED AND THE G7 LINER WAS FOUND TO BE PROLAPSED. ALTHOUGH IT IS POSSIBLE THAT THE LINER WAS NOT PLACED CORRECTLY, BUT THE SURGEON SUGGESTED THAT THE LINER WAS DEFECTIVE. THE LINER WAS REMOVED AND REPLACED WITH A BACK-UP OF THE SAME ITEM LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158112 32MM I.D. SIZE D HIGH WALL LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64987032 00889024520424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown