BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID SCR EPOCA Ø3.5 L24 TAV

    MDR report key: 3988662 · Received August 7, 2014

    Report

    Report Number
    3000270450-2014-10075
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT UNKNOWN. AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER. THE MEDICAL DIRECTOR SAYS , I CAN CONFIRM HEAD DISLOCATION CAN BE OBSERVED. ADDITIONAL PRO CODES: MBF, HSD. (B)(6). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO NCRS GENERATED DURING PRODUCTION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT INITIALLY HAD A DEPUY REVERSE SHOULDER IMPLANTED (DELTA CTA) IN 2007. ON (B)(6) 2013, THE PATIENT FRACTURED THE GLENOID AND AS THERE WERE NO DEPUY PRODUCTS THAT WOULD HAVE SUPPORTED THAT FRACTURE. A SYNTHES EPOCA CAGE WAS PUT INTO THE GLENOID, A DELTA STEM AND THE DEPUY HEMI HEAD REMAINED IN SITU TOGETHER. ON (B)(6) 2014, THE PATIENT HAD UNDERGONE A REVISION, AS A RESULT OF THE SYNTHES SCREWS IMPINGING AND CAUSING PAIN. THE SURGEON THOUGHT THE SCREWS WERE TOO LONG. IN ORDER TO GAIN ACCESS TO THE SCREWS, THE DEPUY HEAD WAS ALSO REMOVED AND REPLACED. IT IS UNDETERMINED WHAT CAUSED THE PAIN, SO EVERYTHING WAS TAKEN OUT AND WAS REPLACED WITH DIFFERENT HARDWARE. ON (B)(6) 2014, THE PATIENT HAD THEN UNDERGONE A THIRD REVISION DUE TO HEAD DISLOCATION BY THE SAME SURGEON AND AT THE SAME HOSPITAL. THERE WAS NO TRAUMA INVOLVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED DISLOCATION. AN X- RAY PHOTO IS PROVIDED ON AN UNKNOWN DATE. THE SURGEON DID NOT MAKE COMMENTS TO INDICATE WHETHER THE PATIENT DISLOCATED DUE TO SOFT TISSUE INSUFFICIENCY OR PRODUCT PERFORMANCE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462833 GLENOID SCR EPOCA Ø3.5 L24 TAV PROSTEHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES SELZACH 11C18940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention