BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 7559918 · Received June 1, 2018

    Report

    Report Number
    0001825034-2018-03743
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    November 28, 2016
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - BIOMET COMPREHENSIVE HUMERAL TRAY WITH LOCKING RING CATALOG#: 115370 LOT #:910020, BIOMET COMPREHENSIVE MINI HUMERAL STEM CATALOG #113630 LOT#836390, BIOMET HUMERAL BEARING CATALOG # XL-115363 LOT#502530. 010000589 COMP RVRS 25MM BSPLT HA+ADPTR 374170. 180550 COMP LK SCR 3.5HEX 4.75X15 ST 758090. 115397 COMP RVS CNTRL 6.5X35MM ST/RST 162000. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES AND X-RAYS. PER THE REVISION OPERATIVE NOTES, THE PATIENT HAD MECHANICAL FAILURE WITH SEVERE BONE LOSS. THE GLENOSPHERE AND BASEPLATE WERE LOOSE WITH A LARGE DEFECT. PER THE CT SCAN RESULTS, THERE WAS SUPERIOR DISPLACEMENT OF THE SCAPULAR COMPONENT WITH ASSOCIATED 18MM BONY FRAGMENT SUGGESTIVE OF A MODERATELY DISPLACED FRACTURE FROM THE ANTERIOR ASPECT OF THE GLENOID AND SCAPULAR SPINE. THERE APPEARS TO BE A NONDISPLACED FRACTURE THROUGH THE BASE OF THE CORACOID PROCESS AS WELL. PER THE X-RAY REVIEW, "COMPLAINT SUGGESTS LOOSENING OF ALL THE SCREWS. THIS COULD BE IDENTIFIED RADIOGRAPHICALLY AS PERIPROSTHETIC LUCENCIES SURROUNDING THE SCREWS. THE ONLY IMAGES THAT SHOW THE SCREWS ARE 1, 2, AND 5. NONE OF THESE IMAGES REVEAL THIS TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURES AND WEAR. PRIOR TO THE REVISION, THE SURGEON ALSO ALLEGEDLY NOTED THAT THE INITIAL COMPONENTS WERE MALPOSITIONED. THE STEM REMAINED IMPLANTED AND ALL OTHER COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405768 COMP LK SCR 3.5HEX 4.75X15 ST PROSTHESIS, SHOULDER SCREW KWS ZIMMER BIOMET, INC. N/A 758090

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R