BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE GLENOID BASEPLATE

    MDR report key: 7321042 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01718
    Event Type
    Injury
    Date Received
    March 7, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PN 180502 SCREW, LN 696450. PN 180501 SCREW, LN 609520. UNKNOWN HUMERAL STEM. UNKNOWN BASEPLATE. UNKNOWN TAPER. PN 115310 COMP RVRS SHLDR GLNS LN 081870. PN 115370 COMP RVS TRAY LN 287370. PN XL-115363 ARCOM XL 44-36 STD HMRL BRNG LN 828610. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL TRAY, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL BEARING, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE TAPER, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE STEM, UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01714, 0001825034-2018-01715, 0001825034-2018-01716, 0001825034-2018-01717, 0001825034-2018-01713.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE EXCRUCIATING PAIN AND LOSS OF FUNCTION THREE MONTHS AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163776 UNKNOWN COMPREHENSIVE REVERSE GLENOID BASEPLATE PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other