BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X35 ST

    MDR report key: 9162349 · Received October 7, 2019

    Report

    Report Number
    0001825034-2019-04517
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    August 20, 2019
    Report Date
    February 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BESIDES AN ANGULATED FRACTURE OF THE INFERIOR THREADED SCREW OF THE GLENOID COMPONENT, THE OVERALL FIT BONE QUALITY APPEARS NORMAL. BONE QUALITY APPEARS NORMAL. NO SIGNS OF LOOSENING, RADIOLUCENCY, OR WEAR. DEVICE HISTORY RECORD 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVRS 25MM BSPLT HA+ADPTR CAT: 010000589 LOT: 994100, 36MM VIT E LINER +0MM CAT: 36MM VIT E LINER +0MM LOT: 64093863, COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 808580, HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH CAT: 00434901213 LOT: 64141144, COMP NLK SCR 3.5HEX 4.75X25 ST CAT: 180559 LOT: 094860, COMP LK SCR 3.5HEX 4.75X15 ST CAT: 180550 LOT: 157510. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956154 COMP LK SCR 3.5HEX 4.75X35 ST SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 082900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R