BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 12X22MM IMPLANT HEAD

    MDR report key: 11365224 · Received February 23, 2021

    Report

    Report Number
    0001825034-2021-00551
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    February 5, 2021
    Report Date
    July 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANT DISASSEMBLY OF A RADIAL HEAD REPLACEMENT WITH LOOSE SCREW AND HEAD AND STEM BOTH LOOSE IN THE ELBOW JOINT. THE SCREW AND HEAD WERE RETURNED BECAUSE THEY CAME LOOSE. THE MOD HEAD THREADS DO NOT APPEAR TO BE DAMAGED. THE ETCHING ON THE HEAD WAS WORN AND COULD NOT IDENTIFY A SPECIFIC LOT NUMBER. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND WAS NOT PROVIDED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: EXPLOR IMPLANT LOCKING SCREW CAT# 11-210099 LOT#NI. 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 - 2021 - 00552.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POSTIMPLANTATION DUE TO DISASSOCIATION. THE SCREW DISENGAGED FROM THE EXPLOR HEAD AND STEM. THE HEAD AND SCREW WERE REMOVED DURING SURGERY. 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
    262808 EXPLOR 12X22MM IMPLANT HEAD PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.