BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 9MM MICRO

    MDR report key: 12165415 · Received July 14, 2021

    Report

    Report Number
    0001825034-2021-02087
    Event Type
    Injury
    Date Received
    July 14, 2021
    Report Date
    November 4, 2021
    Product Code
    MBF
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: VERSA DIAL HEAD: 113053, LOT: 478620. STANDARD TAPER ADAPTER: 118001, LOT 963390. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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). CONCOMITANT MEDICAL DEVICES: ITEM #: UNKNOWN, UNKNOWN HUMERAL TRAY LOT #: UNKNOWN; ITEM #: UNKNOWN, UNKNOWN HUMERAL BEARING 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 - 02088, 0001825034 - 2021 - 02089, 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
    1065935 COMP PRIMARY STEM 9MM MICRO PROSTHESIS, SHOULDER MBF N/A NI
    1065936 COMP PRIMARY STEM 9MM MICRO PROSTHESIS, SHOULDER MBF N/A NI

    Patients

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