BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER GLENOSPHERE

    MDR report key: 10995516 · Received December 12, 2020

    Report

    Report Number
    1818910-2020-26833
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 13, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ()B(). MANUFACTURER REPORT NUMBER 1818910-2020-26833 IS BEING RETRACTED AS IT IS A DUPLICATE OF 1818910-2020-26188. ALL FUTURE REPORTS WILL BE SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1818910-2020-26188. MANUFACTURER REPORT NUMBER 1818910-2020-26833 IS BEING RETRACTED AS IT IS A DUPLICATE OF 1818910-2020-26188. ALL FUTURE REPORTS WILL BE SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1818910-2020-26188.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PROCEDURE 3 (B)(6) 2020 MISS (B)(6). 42 6 PE CUP 1307-42-206 LOT 5339054 REMOVED AND REPLACED WITH: HUMERAL SPACER 1307-30-009 LOT 5336812 AND 42 6 PE CUP 1307-42-206 LOT 5356097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462181 UNKNOWN SHOULDER GLENOSPHERE SHOULDER HUMERAL HEADS KWS DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DXTEND HUMERAL SPACER +9MM| DXTEND STAND PE CUP D42 +6MM