BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X21X57 HUM HEAD

    MDR report key: 12165416 · Received July 14, 2021

    Report

    Report Number
    0001825034-2021-02089
    Event Type
    Injury
    Date Received
    July 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: STANDARD TAPER ADAPTER: 118001, LOT 963390. COMP PRIMARY STEM 9MM MICRO 113609 LOT UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL SHOULDER REPLACEMENT ON AN UNKNOWN DATE. THE SURGEON WANTS TO REVISE THE CONSTRUCT TO A REVERSE SHOULDER REPLACEMENT FOR AN UNKNOWN REASON.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE AVAILABLE FOR EVALUATION: ITEM #: UNKNOWN, UNKNOWN HUMERAL STEM LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN HUMERAL TRAY LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN GLENOSPHERE LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN GLENOID BASEPLATE LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2021-02087, 0001825034-2021-02088, 0001825034-2021-02090, 0001825034-2021-02091.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PMI THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066257 VERSA-DIAL 50X21X57 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 478620
    1066258 VERSA-DIAL 50X21X57 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 478620

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10| SEE H10