BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD EPOCA Ø50 H18.75 SST

    MDR report key: 3870405 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11756
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. NO NONCONFORMANCE REPORTS 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. 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. DATE OF BIRTH REPORTED ONLY AS 1954. THIS REPORT IS FOR THE EPOCA GLENOID, PART AND LOT NUMBER UNKNOWN WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT: COMPLAINED ARTICLE FORWARDED TO THE LEGAL MANUFACTURER FOR EVALUATION. THE INVESTIGATION HAS SHOWN THAT SCREW HEAD IS BROKEN OFF FROM THE SCREW. THE ARTICLES WHERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD SITUATION HAS LED TO THE BREAKAGE. NO PRODUCT FAILURE COULD BE DETECTED. 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 A PATIENT WITH PRIMARY TOTAL SHOULDER PROSTHESIS RETURNED WITH PAIN. AN ARTHROSCOPY WAS PERFORMED (B)(6) 2014 WHICH SHOWED SIGNS OF INFECTION AND A LOOSE GLENOID. ANTIBIOTICS WERE PRESCRIBED AND A REOPERATION WAS PLANNED TO EXTRACT EVERYTHING AND CHANGE TO AN ARTHREX PROSTHESIS, WHICH THEY NORMALLY USE. THE EPOCA STEM (UN-CEMENTED) WAS IMPOSSIBLE TO EXTRACT, THE INSTRUMENT BROKE AND THEY HAD TO CHANGE THE PLAN. THE DECISION WAS TO PUT IN A NEW EPOCA GLENOID, ECCENTER AND HEAD. THIS RESULTED IN A 1 HOUR DELAY, THE PATIENT SLEPT IN THE OPERATING ROOM WHILE THE SURGEON WAITED FOR THE EQUIPMENT. A NEW GLENOID,,ALL POLY,WAS IMPLANTED TOGETHER WITH A REVISION ECCENTER AND HEAD. THE REASON FOR THE FAILURE WAS THE SCREW ( 03.401.077) IN THE EXTRACTION INSTRUMENT (03.401.072 ) THAT BROKE. THIS REPORT IS FOR THE EPOCA GLENOID, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348135 HEAD EPOCA Ø50 H18.75 SST PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES SELZACH 11K14736

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention