BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 11850876 · Received May 19, 2021

    Report

    Report Number
    0001825034-2021-01489
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K120121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4 (LOT NUMBER), UDI# D4 LOT# : 702260 , 800700. D4 UDI# : (B)(4). LOT NUMBER 441630 WAS ISSUED TO 2 FINAL LOTS FOR THE BASEPLATE: LOT 702260 AND LOT 800700. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE TAPER ADAPTER WAS RETURNED AND THE BASE PLATE WAS NOT RETURNED. THE TAPER OF THE TAPER ADAPTER DOES NOT SHOW ANY MAJOR SIGNS OF DAMAGE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2021-01488. 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 THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED AS THE GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746663 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 010000589 B441630 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 115310 COMP RVRS SHLDRGLNSP STD 36MM 830750| 115310 COMP RVRS SHLDRGLNSP STD 36MM 830750