BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW

    MDR report key: 6397309 · Received March 10, 2017

    Report

    Report Number
    0002648920-2017-00188
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 6, 2017
    Report Date
    April 6, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ZIMMER BIOLOX HEAD: CATALOG #: 00877503602, LOT #: 2870271. ZIMMER FEMORAL STEM: CATALOG#: 00771100920, LOT# 63374437. ZIMMER LINER: CATALOG #: 00630505636, LOT #: 63361261. ZIMMER SHELL: CATALOG #: 00620205620, LOT #: 63208174. ZIMMER BONE SCREW: CATALOG #: 00625006525, LOT #: 63535916. ZIMMER BONE SCREW: CATALOG #: 00625006520, LOT #: 63481125. ZIMMER BONE SCREW: CATALOG #: 00625006530, LOT #: 63566049. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500 A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE HEAD OF THE SCREW FRACTURED AND WAS REMOVED, HOWEVER THE BODY OF THE SCREW REMAINS IMPLANTED IN THE PATIENT. COMPLAINT OPERATIVE NOTES WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    DURING INSERTION OF AN ACETABULAR SCREW, THE SCREW FRACTURED ABOVE THE THREADS. THE BROKEN PIECE WAS LOOSE WHILE THE THREADED PORTION OF THE SCREW STAYED IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    DURING A TOTAL HIP ARTHROPLASTY PROCEDURE WHILE THE SURGEON WAS INSERTING A ACETABULAR SCREW IT FRACTURED ABOVE THE THREADS. THE BROKEN PIECE WAS LOOSE AND REMOVED WHILE THE THREADED PORTION OF THE SCREW STAYED IMPLANTED. NO ADVERSE EVENTS WERE A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178080 BONE SCREW PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63566049

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability