BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE HYBRID GLENOID POST REGENEREX

    MDR report key: 7599286 · Received June 13, 2018

    Report

    Report Number
    0001825034-2018-03957
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    April 20, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FROM THE PROVIDED PICTURES IT APPEARS THAT THE GLENOID INSERT WAS NOT UNTHREADED FROM THE POST WHICH IS WHY IT WAS NOT POSSIBLE TO REMOVE THE POST WITH THE GUIDE ROD AS INTENDED. IT IS UNKNOWN WHY THE INSERT WAS NOT/COULD NOT BE UNTHREADED BUT IT IS NOTED THAT THE GLENOID COMPONENT FRACTURING MAY HAVE BEEN A CONTRIBUTING FACTOR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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

    IT WAS REPORTED THAT APPROXIMATELY 4-5 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED FRACTURING OF THE GLENOID COMPONENT, POSSIBLY RELATED TO A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN WHICH DEVICE IS IMPLANTED IN THIS PATIENT'S SHOULDER AND IS BEING REVISED, IT IS ONE OF THE FOLLOWING: LOT # 916870 OR 360780 , EXPIRATION DATE 03/31/2023 OR 01/31/2024. IMPLANT DATE : (B)(6) 2013 OR (B)(6) 2014. CONCOMITANT MEDICAL PRODUCTS: CATALOG # 113954 MD HYBRID GLENOID BASE 4MM LOT # 042230 OR CATALOG # 113952 SM HYBRID GLENOID BASE 4MM LOT # 010150 CATALOG # 118001 VERSA-DIAL/COMP TI STD TAPER LOT # 297470 OR CATALOG # 118001 VERSA-DIAL/COMP TI STD TAPER LOT # 859480 CATALOG # 113630 COMP PRIMARY STEM 10MM MINI LOT # 253090 OR CATALOG # 113632 COMP PRIMARY STEM 12MM MINI LOT # 571370 CATALOG # 113044 VERSA-DIAL 46X21X50 HUM HEAD LOT # 413790 OR CATALOG # 113044 VERSA-DIAL 46X21X50 HUM HEAD LOT # 524560 CATALOG # 402439 COBALT MV BONE CEMENT 40GM B LOT # 606290 OR CATALOG # 402439 COBALT MV BONE CEMENT 40GM B LOT # 700610. (B)(6) 2013 OR (B)(6) 2014. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03957. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR UNKNOWN REASON. AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438817 COMPREHENSIVE HYBRID GLENOID POST REGENEREX PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other