BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 9X30MM IMPL STEM W/SCR

    MDR report key: 14430002 · Received May 18, 2022

    Report

    Report Number
    0001825034-2022-01230
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    January 22, 2020
    Report Date
    May 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: EXPLOR IMPLANT LOCKING SCREW CAT# 11-210099 LOT#NI. EXPLOR 14X24 MM IMPLANT HEAD CAT# 11-210043 LOT#NI. REPORT SOURCE: (B)(6). (B)(4). NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. LEGAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PRIMARY SURGERY: INITIAL RIGHT RADIAL HEAD REPLACEMENT WITH LATERAL LIGAMENT RECONSTRUCTION PERFORMED. 1 WEEK FOLLOW UP: NO COMPLICATIONS ON THE X-RAY. 10 WEEK FOLLOW UP: NO ISSUES NOTED. 30 MONTH FOLLOWUP : CONCERNS WITH ELBOW, ASPIRATION PERFORMED, NEGATIVE FOR GROWTH. X-RAYS INDICATE PROXIMAL MIGRATION OF THE RADIAL HEAD WITH DISPLACEMENT OF THE LOCKING SCREW, CONCERN FOR SEPTIC ARTHRITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT STAGE 1 REVISION WITH PLACEMENT OF ANTIBIOTIC BEADS DUE TO INFECTION. POST-REVISION X-RAYS DEMONSTRATED DESTRUCTIVE CHANGES WITH ASYMMETRY IN THE HUMEROULNAR JOINT WITH VOLAR SHIFT OF THE DISTAL HUMERUS, BUT THE PATIENT HEALED WELL WITH ANTIBIOTIC TREATMENT. 2 MONTH POST REVISION: X-RAY SHOWED DESTRUCTIVE CHANGES IN THE HUMEROULNAR JOINT WITH VOLAR SHIFT OF THE DISTAL HUMERUS, HEALING WELL. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00368, 0001825034 - 2022 - 01231.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 30 MONTHS POST IMPLANTATION DUE TO INFECTION AND MIGRATION OF THE RADIAL HEAD AND LOCKING SCREW. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502935 EXPLOR 9X30MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R