BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP POSITIONER

    MDR report key: 7416917 · Received April 10, 2018

    Report

    Report Number
    0001822565-2018-02090
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 19, 2018
    Report Date
    December 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PB067391
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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. CONCOMITANT PRODUCTS: ZIMMER SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS, ITEM#: 00875705201, LOT#: 63719117; ZIMMER AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14, ITEM#: 0106010104, LOT#: 2905497; ZIMMER LINER 7 MM OFFSET 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL, ITEM#: 00875401036, LOT#: 62492207; ZIMMER BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14, ITEM#: 00877503601, LOT#: 2745788.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE DEVICE SHOWED THE DEVICE FRACTURED AT THE THREAD AND NUT IN THE MIDDLE OF THE DEVICE. THE STRIKE PLATE SHOWED INDENTATIONS FROM USE. THE SHAFT AND HANDLE SHOWED DAMAGE IN THE FORM OF DENTS, DINGS, GOUGES, AND SCRATCHES. THE HARDNESS WAS MEASURED AND IS CONFORMING TO PRINT SPECIFICATIONS. ACCORDING TO SCANNING ELECTRON MICROSCOPY (SEM) RESULTS, THE ANALYSIS IDENTIFIED THE THREAD FRACTURE SURFACE SHOWS MOSTLY GRANULAR SURFACE WITH FRACTURE ARTIFACTS CONSISTENT WITH A BENDING OVERLOAD FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A TOTAL HIP ARTHROPLASTY WHEN THE CUP POSITIONER BROKE IN HALF ON THE LAST HIT OF THE IMPACTION. THE SURGERY WAS NOT DELAYED AND NO SERIOUS INJURY RESULTED TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258866 CUP POSITIONER ORTHOPEDIC INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 62406592

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR