BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PE INLAY EPOCA RECO SIZE 42MM/RIGHT-STERILE

    MDR report key: 6063347 · Received October 28, 2016

    Report

    Report Number
    3000270450-2016-10258
    Event Type
    Injury
    Date Received
    October 28, 2016
    Report Date
    June 3, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODES: MBF AND HSD. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. PHONE NUMBER: (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    (OTHER): UDI # (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 5333-42R, LOT # 13A18239. MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: JUN 12, 2013, EXPIRY DATE: MAY 01, 2018. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INITIAL REPORTER ESTABLISHMENT NAME AND ADDRESS, CONTACT NUMBER (B)(6). 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT HAD FOUR SHOULDER PROCEDURES. THE FOURTH REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO THE PATIENT EXPERIENCING PAIN AND THE GLENOID IMPLANT LOOSENING. ALL THE IMPLANTS WERE REMOVED AND DELTA XTEND DEVICES WERE IMPLANTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716186 PE INLAY EPOCA RECO SIZE 42MM/RIGHT-STERILE PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES SELZACH 13A18239

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention