BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 7X26MM IMPL STEM W/SCR

    MDR report key: 10522174 · Received September 11, 2020

    Report

    Report Number
    0001825034-2020-03394
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 14, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ITEM AND LOT NUMBERS WERE HARD TO READ UNLESS YOU TURN IT THE RIGHT WAY IN THE LIGHT. INSPECTION OF EACH PART FOUND THEM TO BE DAMAGED SUCH AS DEFORMATION, NICKS, GOUGES AND SCRATCH MARKS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE SCREW BACKING OUT LIKELY LED TO THE DISASSOCIATION; HOWEVER, 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: EXPLOR 14X20MM IMPLANT HEAD CAT# 11-210024 LOT# 751940. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03395.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELBOW PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION AS THE SET SCREW BACKED OUT FROM THE HEAD AND STEM. THE HEAD AND SCREW DISASSOCIATED FROM THE STEM AND THE SCREW FLOATED IN THE PATIENT'S ARM. THE SURGEON INDICATED THAT THE SCREW APPEARED TO BE STRIPPED. FURTHER, THE PATIENT HAD OSTEOPENIC BONE; THEREFORE, THE STEM WAS LOOSE AND WAS REMOVED. PATIENT WAS STABLE IN FLEXION AND EXTENSION SO THE SURGEON DECIDED TO KEEP ALL DEVICES OUT AND CLOSE THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985510 EXPLOR 7X26MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. NI 975360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R