BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE

    MDR report key: 6494761 · Received April 14, 2017

    Report

    Report Number
    1719045-2017-10313
    Event Type
    Injury
    Date Received
    April 14, 2017
    Report Date
    March 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4): THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED ACCORDINGLY. THE IMPLANTS HAD TO BE REMOVED DUE TO PAIN. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: MANUFACTURING LOCATION: SUPPLIER (B)(4). PACKAGED BY: (B)(4). MANUFACTURING DATE: 23-APR-2015. EXPIRATION DATE: 31-MAR-2020. PART #: 09.402.020S, LOT#: 7824362 (STERILE) - 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM - STERILE QUANTITY (B)(4). INSPECTION SHEET FOR INCOMING FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 21022 LOT 5345317 AND PART 41060 LOT 9821576 WERE REVIEWED. CERTIFICATE OF COMPLIANCE RECEIVED FROM (B)(4) MEET SPECIFICATION. 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.¿ 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 SYNTHES RADIAL HEAD AND STEM IMPLANT WERE REMOVED UNEVENTFULLY ON (B)(6) 2017. THE REVISION SURGERY WAS SCHEDULED BECAUSE THE PATIENT WAS EXPERIENCING PAIN IN THE EXTENSION INITIALLY IMPLANTED ON AN UNKNOWN DATE. THE SURGEON'S OPINION IS THAT THE STEM WAS LOOSE. NO LOOSENING WAS OBSERVED OR CONFIRMED, IT WAS THE SURGEONS OPINION. AFTER REMOVAL OF THE IMPLANT, THE SURGEON IMPLANTED AN ACUMED RADIAL HEAD AND STEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT STATUS WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275114 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7824362

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention