BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR MODULAR RADIAL STEM WITH SCREW

    MDR report key: 19547453 · Received June 17, 2024

    Report

    Report Number
    0001825034-2024-01617
    Event Type
    Injury
    Date Received
    June 17, 2024
    Report Date
    October 25, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    UDI-DI
    00880304210455
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; D2; G1; G3; G6; H1; H2; H3; H6. H6: PROPOSED ANNEX G CODE MECHANICAL (G04) STEM. MEDICAL RECORDS CONFIRM THE REPORTED EVENT OF PAIN AND SWELLING. HOWEVER, THE REPORTED EVENT OF AN ALLERGIC REACTION IS NOT CONFIRMED AS THE IMPLANTS DO INCLUDE THE COMPOUNDS THAT THE PATIENT IS ALLERGIC TO (FERRIC FLUORIDE AND MANGANESE FLUORIDE). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. RADIOGRAPHS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - 11-210031 (65737274). - 11-210099 (341750). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN INITIAL LEFT RADIAL HEAD ARTHROPLASTY, THE PATIENT ALLEGED THAT THEY WERE EXPERIENCING PAIN, SWELLING, NAUSEA, WEAKNESS, AND A POSSIBLE ALLERGIC REACTION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316897 EXPLOR MODULAR RADIAL STEM WITH SCREW PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI ZIMMER BIOMET, INC. NI 66192759 00880304210455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other H11.