BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM COCR RADIAL HEAD 2MM HT EXTENSION/15.0MM-STER

    MDR report key: 6352531 · Received February 23, 2017

    Report

    Report Number
    1719045-2017-10135
    Event Type
    Injury
    Date Received
    February 23, 2017
    Report Date
    January 26, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS (B)(6). PATIENT DATE OF BIRTH NOT PROVIDED FOR REPORTING. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 09.402.224S AND LOT # 6905446 (STERILE) - 24 MM COCR RADIAL HEAD 2 MM HT EXTENSION/15.0 MM - STERILE. QUANTITY 33: MANUFACTURING LOCATION: SUPPLIER (B)(4), PACKAGED BY: (B)(4), MANUFACTURING DATE: 21-DEC-2012, EXPIRATION DATE: 30-NOV-2017. NO NON-CONFORMANCE REPORTS (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. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL 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

    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 PATIENT WAS IMPLANTED WITH A RADIAL HEAD AND RADIAL STEM IN THE PROXIMAL RADIUS ON (B)(6) 2016. NO REPORTED ISSUES WITH INITIAL SURGERY. POSTOPERATIVELY, ON AN UNKNOWN DATE THE PATIENT REPORTED PAIN, DISCOMFORT AND IMPINGEMENT. PATIENT WAS SEEN BY A SURGEON ON (B)(6) 2017. IT IS UNKNOWN WHEN X-RAYS WERE TAKEN HOWEVER; X-RAYS SHOWED THAT THE RADIAL HEAD IS IMPINGING ON THE PATIENT¿S CAPITULUM. SURGEON BELIEVED THAT THE RADIAL STEM HAS LOOSENED AND IS CAUSING THE IMPINGEMENT. A REVISION SURGERY HAS BEEN RESCHEDULED FOR (B)(6) 2017. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL OFF A FOUR FEET LADDER AND LANDED DIRECTLY ON HIS ELBOW INJURING HIS PROXIMAL RADIUS AND PROXIMAL ULNA ON UNKNOWN DATE. PATIENT SUSTAINED A TYPE II B CORONOID FRACTURE AT THE PROXIMAL ULNA AND WAS NOT SURGICALLY FIXED WITH HARDWARE. POSTOPERATIVELY PATIENT ALSO COMPLAINED ABOUT LOOSENING. REVISION SURGERY OCCURRED ON (B)(6) 2017 WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND PATIENT WAS REPORTED AS STABLE. BOTH IMPLANTS WERE EXPLANTED INTACT AND NEW RADIAL HEAD AND NEW RADIAL STEM WAS IMPLANTED WITH BONE GRAFT WITHOUT ANY ISSUES. ALL THE NEW IMPLANTS USED IN REVISION SURGERY WERE NON - SYNTHES. X-RAYS TAKEN POST OP ((B)(6) 2016) SURGERY) WERE NOT AVAILABLE FOR RETURN. BOTH RADIAL HEAD AND RADIAL STEM WERE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135257 24MM COCR RADIAL HEAD 2MM HT EXTENSION/15.0MM-STER PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6905446

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention