BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS APEX HUMERAL STEM, 10MM

    MDR report key: 8209505 · Received January 2, 2019

    Report

    Report Number
    1220246-2019-00831
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867134607
    PMA / PMN Number
    K131633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2017 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-10S LOT: 10055062; AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION TSA/GLENOID REVISION AND HUMERAL HEAD SIZE REDUCTION (CAPTURED ON CASE (B)(4)) FOR AN UNKNOWN REASON AND THE FOLLOWING DEVICES WERE EXPLANTED: AR-9106-01 LOT: 1027261611 (MEDWATCH 1220246-2019-00828) AND AR-9146-20P LOT: 160051618 (MEDWATCH 1220246-2019-00829) AND REPLACED WITH: AR-9105-01 LOT: 113601629 AND AR-9144-19P LOT: 160047318. THE PATIENT THEN UNDERWENT A SECOND REVISION TSA ON (B)(6) 2018. UPON ENTERING THE JOINT SPACE, THE SURGEON REALIZED THE HEAD WAS BARELY ASSOCIATED TO THE "TRUNION". MOREOVER, THE "TRUNION" WAS DISASSOCIATED FROM THE STEM AS WELL AND THE SUPERIOR VERSION SCREW WAS BACKED ALL THE WAY OUT. ESSENTIALLY THE STEM FELL APART INTO 4 PIECES: THE SCREW, THE HEAD, THE STEM, AND THE "TRUNION". THE FOLLOWING DEVICES WERE EXPLANTED AND REPLACED WITH A SYSTEM FROM ANOTHER MANUFACTURER: AR-9100-10S LOT: 10055062 (IMPLANTED DURING (B)(6) 2017 ORIGINAL PROCEDURE); AR-9105-01 LOT: 113601629 (IMPLANTED DURING (B)(6) 2017 REVISION PROCEDURE) AND AR-9144-19P LOT: 160047318 (IMPLANTED DURING (B)(6) 2017 REVISION PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225 UNIVERS APEX HUMERAL STEM, 10MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 10MM 10055062 00888867134607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other