BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

    MDR report key: 5555709 · Received April 7, 2016

    Report

    Report Number
    2520274-2016-12015
    Event Type
    Injury
    Date Received
    April 7, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DOB & WEIGHT NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. UNK-PRODUCT - WITH LIMITED AND OR NO INFORMATION ON THE PART, ADDITIONAL PRODUCT CODES TO INCLUDE: HSD, KWT, KWY, MDI , MJO, NEI. THIS REPORT IS FOR AN UNKNOWN PROSTHESIS/UNKNOWN LOT NUMBER. OTHER: UDI: UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, UDI IS UNAVAILABLE. IMPLANT AND EXPLANT DATES: UNKNOWN WHEN IMPLANTED OR EXPLANTED. CODE USED FOR: THIS DEVICE WAS REPORTED AS RUPTURED AND REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REPLACE THE DEVICE. PM 510K#: UNKNOWN. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE HOSPITAL BOUGHT A PROSTHESIS TO BE USED IN A SURGERY BUT IT BROKE ON THE DAY OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM TRANSLATED FORMAL LETTER ON (B)(6) 2016 VIA E-MAIL: ON THE DAY OF THE OPERATION THE PROSTHESIS RUPTURED AND AS A RESULT, HAD TO BE REPLACED WITH A DIFFERENT ONE AT THAT TIME. MORE INFORMATION FORTH COMING 20APR2016. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209607 PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER KWI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention