BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 6491301 · Received April 13, 2017

    Report

    Report Number
    0001825034-2017-02554
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    September 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT YET INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE DEVICES REMAINED IMPLANTED AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02526/ 0001825034-2017-02553/0001825034-2017-02555/ 0001825034-2017-02556/ 0001825034-2017-02557. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-02806/ (B)(4)/ 1825034-2016-03470/ 1825034-2016-04831/ 0001825034-2016-02804/ 0001825034-2016-02805. MEDICAL PRODUCTS-COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CATALOG: 115310, LOT#868870, VERSA DIAL TAPER CATALOG#:118001 LOT#:378870, STEM CATALOG#:113652 LOT#:496560, TRAY CATALOG#:115370 LOT#:UNK, HUMERAL BEARING CATALOG#:XL-115363 LOT#:369090, VERSA DIAL TAPER CATALOG#:118001 LOT#:707740, SHOULDER GLENOID BASEPLATE CATALOG#:115330 LOT#:422790, STEM CATALOG#:113632 LOT#:485330, COMPREHENSIVE CENTRAL SCREW CATALOG#: 115383 LOT#:787000, HUMERAL BEARING CATALOG#:XL-115363 LOT#:950910, REVERSE SHOULDER CATALOG#:115310 LOT#:921470, HUMERAL BEARING CATALOG#: XL-115363 LOT#:450680.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING PAIN AND HEADACHES APPROXIMATELY EIGHT MONTHS FOLLOWING REVISION SHOULDER PROCEDURE. NO REVISION PROCEDURE HAS BEEN INDICATED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271690 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW PROTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 424640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other