BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 9MM MICRO

    MDR report key: 7188876 · Received January 15, 2018

    Report

    Report Number
    0001825034-2018-00200
    Event Type
    Injury
    Date Received
    January 15, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): A 115313, COMP RVSR SHLDR GLNSP +3 36MM, 378610. A 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, 563340. A 115396, COMP RVS CNTRL 6.5X30MM ST/RST, 046620. A 115370, COMP RVS TRAY CO 44MM, 083400. A 180550, COMP LK SCR 3.5HEX 4.75X15 ST, 280260. A 180556, COMP LK SCR 3.5HEX 4.75X45 ST, 186540. A 180554, COMP LK SCR 3.5HEX 4.75X35 ST, 541870. XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 963740. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00199, 0001825034 - 2018 - 00198, 0001825034 - 2018 - 00201, 0001825034 - 2018 - 00202, 0001825034 - 2018 - 00203, 0001825034 - 2018 - 00204, 0001825034 - 2018 - 00205, 0001825034 - 2018 - 00206. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND A POSSIBLE ALLERGIC REACTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35292 COMP PRIMARY STEM 9MM MICRO PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 919730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other