BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LG HYBRID GLENOID BASE 4MM

    MDR report key: 6904998 · Received September 29, 2017

    Report

    Report Number
    0001825034-2017-07440
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    April 22, 2016
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT PRODUCTS: UNKNOWN, UNKNOWN HUMERAL STEM, UNKNOWN. UNKNOWN, UNKNOWN TAPER ADAPTER, UNKNOWN. UNKNOWN, UNKNOWN BASEPLATE, UNKNOWN. UNKNOWN, UNKNOWN TRAY, UNKNOWN. UNKNOWN, UNKNOWN HUMERAL BEARING, UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07439. 0001825034 - 2017 - 07441. 0001825034 - 2017 - 07442. 0001825034 - 2017 - 07443. 0001825034 - 2017 - 07444.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- PART: 113956 NAME: LG GLENOID BASE LOT: 240070, PART: 113654 COMP PRIMARY STEM LOT: 624050, PART: PT-113950 NAME: PT HYBRID GLEN POST REGENEREX LOT: 271210, PART: 118001 VERSA-DIAL/COMP TI STD TAPER LOT: 800720, PART: 113053 VERSA-DIAL 50X21X57 HUM HEAD LOT: 605230, PART: 405800 COMP. REV SHLDR 9 IN STEINMANN LOT: 905780. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING UNKNOWN COMPLICATIONS WITH HIS RIGHT SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER REPLACEMENT DUE TO UNKNOWN REASONS. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684691 LG HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 240070

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other