BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHDR GLEN BSPLT +HA

    MDR report key: 7428415 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02559
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    November 3, 2015
    Report Date
    June 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): EP-115393, E1 44-36 STD HMRL BRNG, 944430; 115310, COMP RVRS SHLDR GLNSP STD 36MM, 996760; 118001, VERSA-DIAL/COMP TI STD TAPER, 080410; 115395, COMP RVS CNTRL 6.5X25MM ST/RST, 515140; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 816790; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 704760; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 327130; CP561548, CSTM BI-ANG REV SHLD 44MM TRAY, 730420. 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 - 02557, 0001825034 - 2018 - 02558, 0001825034 - 2018 - 02556, 0001825034 - 2018 - 02560, 0001825034 - 2018 - 02561, 0001825034 - 2018 - 02562, 0001825034 - 2018 - 02563. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. SINGLE AP FILM OF THE RIGHT SHOULDER DEMONSTRATES A RIGHT SHOULDER REVERSE ARTHROPLASTY IN PLACE WITH THIN CEMENT MANTLE OF THE HUMERAL COMPONENT. THERE IS LUCENCY ALONG THE BASE OF THE SUPERIOR AND INFERIOR ASPECT OF THE GLENOSPHERE. THE INFERIOR SCREW DOES NOT APPEAR TO BE SEATED WITHIN THE BONE. PRESUMED POSTSURGICAL CHANGES FROM RECENT RIGHT SHOULDER REVERSE ARTHROPLASTY WITH LUCENCY ALONG THE BASE OF THE GLENOSPHERE WHICH COULD SUGGEST LOOSENING. INFERIOR SCREW OF THE GLENOID PLATE DOES NOT APPEAR TO BE SEATED WITHIN BONE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 A REVISION SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, INSTABILITY, AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272588 COMP RVRS SHDR GLEN BSPLT +HA PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 447650 

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R