BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR MODULAR RADIAL STEM WITH SCREW

    MDR report key: 6673455 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04362
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    May 15, 2017
    Report Date
    October 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: EXPLOR 10X24 MM IMPLANT HEAD CATALOG # 11-210041, LOT NUMBER # 776810. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034 - 2017 - 04362 / 0001825034 - 2017 - 04378).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIAL HEAD ELBOW ARTHROPLASTY REVISION APPROXIMATELY TEN (10) MONTHS POST-OPERATIVELY DUE TO DISASSOCIATION OF THE STEM AND RADIAL HEAD, SECONDARY TO MOBILIZATION OF THE SCREW. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE IN PROGRESS, HOWEVER FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453724 EXPLOR MODULAR RADIAL STEM WITH SCREW PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI BIOMET ORTHOPEDICS N/A 987390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R