BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD HEAD ¿22 UNCEM H14.5 W/EXT 2 TAN/COC

    MDR report key: 6408499 · Received March 15, 2017

    Report

    Report Number
    1719045-2017-10223
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    February 21, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PARTS WERE NOT RETURNED FOR EVALUATION. THE INVESTIGATION HAS CONFIRMED THAT THESE IMPLANTS ARE SUBJECTED TO DELIVERY STOP AND THE PARTS ARE CONSEQUENTLY BLOCKED IN THE ENTERPRISE RESOURCE PLANNING SYSTEM. IN ADDITION, ON 30 DECEMBER 2016 SYNTHES (B)(4) HAS INITIATED A VOLUNTARY MEDICAL DEVICE REMOVAL (RECALL) OF THE DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM DUE TO THE POSSIBILITY THAT THE RADIAL STEM MAY LOOSEN POST-OPERATIVELY AT THE STEM BONE INTERFACE. ANY RELATED INVESTIGATIONS AND ASSESSMENT OF THE RISKS ASSOCIATED WITH THIS SYSTEM WILL BE COVERED UNDER RECALL AND CORRECTIVE AND PREVENTATIVE ACTIONS WERE INITIATED IN ORDER TO DETERMINE THE ROOT CAUSE(S) AND DOCUMENT THE CORRECTION(S), CORRECTIVE ACTION(S) AND/OR PREVENTIVE ACTION(S). 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 USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4): THE PATIETNT IS EXPERIENCING DISCOMFORT, HOWEVER THERE IS NO REPORTS OF DEVICE REMOVAL AT THIS TIME. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED ACCORDINGLY. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART 09.402.222S / LOT 7529691; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 18-NOV-2013; EXPIRATION DATE: 30-NOV-2018. PART #: 09.402.222S, LOT#: 7529691 (STERILE) - 22MM COCR RADIAL HEAD 2MM HT EXTENSION/14.5MM - STERILE. QUANTITY (B)(4). COMPONENT PARTS REVIEWED: PART 09.402.222S 22MM COCR RADIAL HEAD, LOT 7013436. 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A SURGERY AND RADIAL HEAD PROSTHESIS WERE IMPLANTED. THE PATIENT IS SATISFIED WITH THE RESULT BUT NOT TOTALLY FREE OF DISCOMFORT. ON X-RAYS WAS SEEN THAT THE SHAFT HAD LOOSEN POST-OPERATIVELY. NO REVISION SURGERY WILL BE PERFORMED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189151 RAD HEAD ¿22 UNCEM H14.5 W/EXT 2 TAN/COC PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7529691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention