BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 14MM MINI

    MDR report key: 10137813 · Received June 10, 2020

    Report

    Report Number
    0001825034-2020-01839
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    December 6, 2019
    Report Date
    June 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304449732
    PMA / PMN Number
    K060692
    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 · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 118001; VERSA-DIAL/COMP TI STD TAPER; LOT# 349060. ITEM# 110031424; CR VIVACIT-E 36MM BRNG STD; LOT# 64343846. 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. FOREIGN: EVENT HAPPENED IN (B)(6). THE REPORTED EVENT WAS CONFIRMED BY A REVIEW OF X-RAYS. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SEPARATION OF THE GLENOSPHERE FROM THE BASE PLATE OF THE REVERSE-TYPE RIGHT SHOULDER ARTHROPLASTY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05661, 0001825034-2019-05662.

    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. THE COMPREHENSIVE STEM HAD FRACTURED. 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
    602658 COMP PRIMARY STEM 14MM MINI PROSTHESIS, EXTREMITIES HSD ZIMMER BIOMET, INC. N/A 300540 00880304449732

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R