BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR VIVACIT-E 36MM BRNG STD

    MDR report key: 9558360 · Received January 7, 2020

    Report

    Report Number
    0001822565-2019-05379
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    December 7, 2019
    Report Date
    June 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868231551
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SEPARATION OF THE GLENOSPHERE FROM THE BASE PLATE OF THE REVERSE-TYPE RIGHT SHOULDER ARTHROPLASTY AND THE HUMERUS IS SLIGHTLY ELEVATED IN RELATION TO THE GLENOID. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION: IMPLANT DATE IS CORRECTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#113634; COMP PRIMARY STEM 14MM MINI; LOT# 300540, ITEM# 110031402; MINI TRAY STD COCR +3 OFFSET; LOT# 64327562, ITEM# 115310; COMP RVRS SHLDR GLNSP STD 36MM; LOT# 664970, ITEM# 115395; COMP RVS CNTRL 6.5X25MM ST/RST; LOT# 139000, ITEM# 180558; COMP NLK SCR 3.5HEX 4.75X20 ST; LOT# 236640, ITEM# 180552; COMP LK SCR 3.5HEX 4.75X25 ST; LOT# 795520, ITEM# 180551; COMP LK SCR 3.5HEX 4.75X20 ST; LOT# 641130, ITEM# 115330; COMP RVRS SHDR GLEN BSPLT +HA; LOT# 760180, ITEM# 118001; VERSA-DIAL/COMP TI STD TAPER; LOT# 349060. REPORT SOURCE: (B)(6). 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: 0001822565-2019-05380. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES.. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19859 CR VIVACIT-E 36MM BRNG STD PROSTHESIS, EXTREMITIES KWS ZIMMER BIOMET, INC. N/A 64343846 00887868231551

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R