BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 12X22MM IMPLANT HEAD

    MDR report key: 12335842 · Received August 18, 2021

    Report

    Report Number
    0001825034-2021-02294
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 26, 2021
    Report Date
    October 28, 2021
    Product Code
    JDB
    UDI-DI
    00880304210387
    PMA / PMN Number
    NI
    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. VISUAL EXAMINATION OF THE RETURNED PRODUCT VERIFIED LOT NUMBER. COSMETIC INSPECTION OF THE PRODUCT FOUND NO MAJOR COSMETIC DAMAGES. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT ELBOW RADIAL HEAD REPLACEMENT WITH EVIDENCE OF A SCREW WITHIN THE ELBOW JOINT. OBLIQUE APPEARANCE OF THE RADIAL HEAD REPLACEMENT COULD INDICATE LOOSENING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 PRODUCTS: EXPLOR IMPLANT LOCKING SCREW CAT# 11-210099 LOT# UNK. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2021-02295.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO DISASSOCIATION OF THE MODULAR HEAD AND LOCKING SCREW. HEAD AND SCREW WERE BOTH REPLACED BUT THE STEM COULD NOT BE REMOVED. 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
    1235484 EXPLOR 12X22MM IMPLANT HEAD PROSTHESIS, ELBOW JDB NI 419620 00880304210387

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10