BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVS CUP,42/NEUTRAL CTD

    MDR report key: 7884924 · Received September 18, 2018

    Report

    Report Number
    1220246-2018-00645
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 18, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867061187
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALED BOTH THE SCREW AND THE RAISED SIDE OF THE SCREW HOLE ON THE CUP HAD FRACTURED. THE FRAGMENTS WERE NOT RECEIVED FOR EVALUATION. THE OPPOSITE SIDE OF THE FRACTURED HOLE WAS ALSO DAMAGED. IN ADDITION, THERE WERE SCRATCHES AND TOOL MARKS ON BOTH INNER AND OUTER SURFACES PLUS A VISIBLE WEAR PATTERN WAS OBSERVED. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. A ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION SURGERY. ORIGINAL DATE OF SURGERY WAS (B)(6) 2015. PER THE REP, THE AR-9502-42CPC BROKE IN HALF IN THE PATIENT WHEN HE WAS OPENING A BOTTLE OF WATER. THE REVISION WAS (B)(6) 2018. PARTS REMOVED WERE AR-9502-42CPC (LOT 12.714), AR-9550-12 (LOT 13.490) AND A ¿LINER¿ (NO PART # FOUND PER THE REP). THESE WERE REPLACED WITH AR-9502F-42CPC AND AR-9550-15. THE ORIGINAL CUP WAS DONE AT THE 135 DEGREE SLOT; THE REVISION WAS DONE AT THE 155 DEGREE SLOT. ORIGINAL SURGERY WAS DONE IN (B)(6), REVISION IN (B)(6) (DIFFERENT SURGEONS). ADDITIONAL INFORMATION OBTAINED 9/13/18: THE SALES REP HAS CONFIRMED THAT, PER THE SURGEON'S DECISION, THE DISTAL PART OF A SCREW, WHICH IS PART OF THE UNIVERSAL REVERSE CUP (AR-9502-42CPC), WAS STUCK IN THE 135 DEGREE HOLE OF THE UNIVERSAL REVERSE STEM THAT WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726939 UNIVERS REVS CUP,42/NEUTRAL CTD SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERS REVS CUP,42/NEUTRAL CTD 12.714 00888867061187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other