BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHDR GLEN BSPLT +HA

    MDR report key: 7402874 · Received April 6, 2018

    Report

    Report Number
    0001825034-2018-02404
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    March 19, 2015
    Report Date
    April 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 118001, COMPREHENSIVE VERSA-DIAL/COMP TI STD TAPER, 780060. THE 115370, COMP RVS TRAY CO 44 MM, 654490. THE 113654, COMP PRIMARY STEM 14 MM STD, 287120. THE TI-115313, COMP VRSDL GLNSPR 36 MM +3 TI, 799480. THE XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, 256230. THE 115395, COMP RVS CNTRL 6.5 X 25 MM ST/RST, 711530. THE 180559, COMP NLK SCR 3.5 HEX 4.75X25 ST, 916660. THE 180560, COMP NLK SCR 3.5 HEX 4.75X30 ST, 900470. THE 180559, COMP NLK SCR 3.5 HEX 4.75X25 ST, 150290. THE 180552, COMP LK SCR 3.5 HEX 4.75X25 ST, 653810. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. PER THE REVISION OPERATIVE REPORT, PRE-OP X-RAYS CONFIRMED THAT THE GLENOSPHERE HAD PULLED OUT OF THE BASEPLATE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018- 02403.

    Additional Manufacturer Narrative · 1

    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 BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE DUE TO MECHANICAL DISSOCIATION OF RIGHT SHOULDER ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245373 COMP RVRS SHDR GLEN BSPLT +HA PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 322750

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R