BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI CURVED RADIAL STEM 42MM-STERILE

    MDR report key: 6486086 · Received April 12, 2017

    Report

    Report Number
    1719045-2017-10299
    Event Type
    Injury
    Date Received
    April 12, 2017
    Report Date
    March 24, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL. A RECALL Z NUMBER CORRECTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART 04.402.027S, LOT 7012309: MANUFACTURING LOCATION: SUPPLIER (B)(4), PACKAGED BY: (B)(4). MANUFACTURING DATE: JANUARY 03, 2013. EXPIRATION DATE: NOVEMBER 30, 2017. RAW MATERIAL WAS REVIEWED. INSPECTION SHEET FOR INCOMING FINAL INSPECTION MEET INSPECTION CRITERIA. CERTIFICATE OF COMPLIANCE FROM (B)(4) MEET SPECIFICATION. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIAL HEAD CONSTRUCT WAS LOOSENING CAUSING IN NOT TO HEAL CORRECTLY. A REVISION SURGERY TO REMOVE THE STEM AND HEAD WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS REVISED WITH A NON-SYNTHES CONSTRUCT. THERE SURGERY WAS COMPLETED SUCCESSFULLY, NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY AND THE PATIENT WAS STABLE FOLLOWING SURGERY THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268142 7MM TI CURVED RADIAL STEM 42MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7012309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention