BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

    MDR report key: 6721208 · Received July 18, 2017

    Report

    Report Number
    1719045-2017-10654
    Event Type
    Injury
    Date Received
    July 18, 2017
    Report Date
    June 20, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF DEVICE LOOSENING IS NOT KNOWN. (B)(4). DATE OF IMPLANT REPORTED AS APPROXIMATELY ONE YEAR PRIOR TO EXPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICE THERAPY DATE REPORTED AS APPROXIMATELY ONE YEAR PRIOR TO EXPLANT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART #: 04.402.007S, LOT#: 9895683 (STERILE) - 7 MM TI STRAIGHT RADIAL STEM 26 MM - STERILE. QUANTITY 25. LOT 9895683 WAS SPLIT TO LOT H081283 AT OPERATION 30 GENERATING LABEL FOR QUANTITY 25. INSPECTION SHEET FOR INCOMING FINAL INSPECTION, CERTIFICATE OF COMPLIANCE RECEIVED FROM (B)(4) AND RAW MATERIAL LOT: 7557656 WERE REVIEWED. NO NCRS 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.¿ MANUFACTURING LOCATION: SUPPLIER (B)(4). PACKAGED BY: (B)(4). MANUFACTURING DATE: 25-APR-2016. EXPIRATION DATE: 31-MAR-2021. 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

    RECALL REPORTING NUMBER. 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 A HARDWARE REMOVAL OF A RADIAL HEAD PROSTHESIS WAS PERFORMED ON (B)(6) 2017 DUE TO PATIENT'S COMPLAINT THAT THE IMPLANT WAS "BOTHERING HER". THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, APPROXIMATELY ONE YEAR PRIOR TO THE REMOVAL DATE. BOTH THE RADIAL HEAD AND RADIAL STEM WERE REMOVED EASILY AND INTACT. DURING THE REMOVAL, THE SURGEON NOTICED THAT THE STEM WAS LOOSE IN THE CANAL. THERE WAS NO REPORTED SURGICAL DELAY, NO ADDITIONAL X-RAYS OR OTHER INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: RADIAL HEAD PROSTHESIS (PART 09.402.024S, LOT 7608119, QUANTITY 1). THIS REPORT IS FOR ONE (1) 7 MM TITANIUM STRAIGHT RADIAL STEM 26 MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502338 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 9895683

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RADIAL HEAD (09.402.024S, LOT 7608119, QTY 1)