BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR VIVACIT-E 36MM BRNG STD

    MDR report key: 16462025 · Received March 1, 2023

    Report

    Report Number
    0001822565-2023-00557
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    March 16, 2021
    Report Date
    May 23, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00887868231551
    PMA / PMN Number
    K191459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2023-00558. CONCOMITANT MEDICAL PRODUCT: MINI TRAY +5MM COCR +0 OFFSET, CAT: 110031400 LOT: 65011425; COMP RVRS 25MM BSPLT HA+ADPTR, CAT: 010000589 LOT: 865310; COMP RVRS SHLDR GLNSP STD 36MM, CAT: 115310 LOT: 295150; COMP LK SCR 3.5HEX 4.75X15 ST, CAT: 180550 LOT: 844770; COMP LK SCR 3.5HEX 4.75X15 ST, CAT: 180550 LOT: 835900; COMP RVS CNTRL 6.5X20MM ST/RST, CAT: 115394 LOT: 042470; COMP LK SCR 3.5HEX 4.75X25 ST, CAT: 180552 LOT: 591580; COMP LK SCR 3.5HEX 4.75X25 ST, CAT: 180552 LOT: 591160; COMP PRIMARY STEM 11MM MINI, CAT: 113631 LOT: 64810566. 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 REPORT WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SINGLE AP VIEW OF THE RIGHT SHOULDER DEMONSTRATES A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH POSSIBLE RADIOLUCENT SPACER NOTED SUPERIOR TO THE JOINT SPACE. BONY FRAGMENT NOTED ALONG THE INFERIOR GLENOHUMERAL JOINT; THOUGHT TO BE FROM THE INFERIOR GLENOID BUT CANNOT DETERMINE DEFINITIVELY. THESE TWO COMPLICATIONS MAY HAVE OCCURRED WHEN THE PATIENT WAS PULLING HIS TRASHCAN. NO RADIOLUCENCY. NORMAL BONE QUALITY. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT WHEN THE PATIENT WAS PULLING THE TRASH CAN, THEIR SHOULDER FELT STRANGE. THE PATIENT FURTHER REPORTED SHOULDER DISCOMFORT AND NOTICEABLE GRINDING SENSATION WITH MOVEMENT FOLLOWING THIS EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123782 CR VIVACIT-E 36MM BRNG STD SHOULDER, PROSTHESIS MBI ZIMMER BIOMET, INC. N/A 64833610 00887868231551

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other