BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, LARGE

    MDR report key: 6431855 · Received March 24, 2017

    Report

    Report Number
    1220246-2017-00091
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 15, 2017
    Report Date
    March 27, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057333
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF FOUR SUBMISSIONS FOR THE SAME EVENT. THE OTHERS ARE CC108390-LINE 187579-00092, CC108390-LINE 187581-00093 AND CC108390-LINE 187584-00094. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION REVEALED SEVERE DEEP SCRAPE MARKS ON THE NON-ARTICULATING SURFACE. THE TWO PEGS AND THE BARBS ON THE NON-ARTICULATING SURFACE HAVE GOUGING MARKS. THERE ARE NORMAL WEAR PATTERNS AND IRREGULAR SURFACE TEXTURE ON THE ARTICULATING SURFACE. THE DAMAGES OBSERVED ARE CONSISTENT WITH EXTRACTION MARKS. UNABLE TO COMPLETE DIMENSIONAL ANALYSIS OF COMPLAINT PART DUE TO THE EXTENT OF THE DAMAGE. AT THIS TIME, IT CANNOT BE DETERMINED HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD ORIGINAL ECLIPSE SURGERY IN 2013. GLENOID AR-9105-03, (LOT 1230011) (CC108390 LINE 186146), SCREW-AR-9301-02, (LOT 1127024) (CC108390 LINE 187579), TRUNION-AR-9300-49CPC, (LOT 1128006) (CC180390 LINE 187581), HUMERAL HEAD- AR-9349-18, (LOT 947018) (CC180390 LINE 187584) WERE IMPLANTED. FOLLOW-UP SERIAL X RAYS SHOWED INCREASING LUCENT LINES AROUND THE PEGGED GLENOID. PATIENT HAD PAIN AND DECISION WAS MADE TO REVISE TO A REVERS PER SURGEON. REVISION TOOK PLACE ON (B)(6) 2017. THE HUMERAL COMPONENT WAS REMOVED WITHOUT ISSUE. SALES REP NOTED THAT THE ECLIPSE PROSTHESIS WAS EXTREMELY WELL FIXED AND THE CAGE SCREW HAD COMPLETE BONE THROUGH GROWTH. THE GLENOID WAS LOOSE AND WAS REMOVED BY HAND WITH PEGS INTACT. CEMENT WAS REMOVED FROM THE GLENOID. AUTOGRAFT WAS TAKEN FROM THE ILIAC CREST TO ADDRESS THE BONE DEFECT IN THE GLENOID. THE ALLOGRAFT WAS PREPARED FOR THE REVERS BASE PLATE IN SITU PRIOR TO HARVESTING THE GRAFT. THE BASEPLATE WAS THEN TRIED TO MATCH THE BONE DEFECT. THE BONE GRAFT AND BASE PLATE WERE IMPLANTED AND FIXATED WITH THE BASEPLATE SCREWS. THE REST OF THE REVERS SURGICAL TECHNIQUE WAS FOLLOWED TO COMPLETE THE CASE. PATIENT WAS A (B)(6) MALE, DOB (B)(6). THE FOLLOWING INFORMATION WAS OBTAINED FROM PATIENT MEDICAL RECORDS PROVIDED (B)(6) 2017: OPERATIVE REPORT (B)(6) 2013 SURGERY: DATE OF ORIGINAL SURGERY WAS (B)(6) 2013. HOSPITAL MEDICAL RECORDS (B)(6) 2017 THROUGH (B)(6) 2017: PATIENT WAS ORIGINALLY SCHEDULED TO BE DISCHARGED ON (B)(6)2017. SURGEON CHOSE TO EXTEND ONE ADDITIONAL DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214800 GLENOID, PE WITH PEG, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 1230011 00888867057333

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other