BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL SCR 6.5X30MM ST

    MDR report key: 7832151 · Received August 30, 2018

    Report

    Report Number
    0001825034-2018-08625
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    June 12, 2014
    Report Date
    November 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG # LOT # 180558 354080 COMP NLK SCR 3.5HEX 4.75X20 ST, 180553 585670 COMP LK SCR 3.5HEX 4.75X30 ST, 180554 705780 COMP LK SCR 3.5HEX 4.75X35 ST, 115370 766930 COMP RVS TRAY CO 44MM, 010000589 978220 COMP RVRS 25MM BSPLT HA+ADPTR, 180558 354080 COMP NLK SCR 3.5HEX 4.75X20 ST, 115310 677090 COMP RVRS SHLDR GLNSP STD 36MM, XL-115363 478460 ARCOM XL 44-36 STD HMRL BRNG, 113629 318760 COMP PRIMARY STEM 9MM MINI. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATIONS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08620, 0001825034-2018-08621, 0001825034-2018-08623, 0001825034-2018-08626, 0001825034-2018-08627, 0001825034-2018-08624, 0001825034-2018-08622. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED TO A HEMI-SHOULDER AFTER AN INFECTION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675252 COMP RVS CNTRL SCR 6.5X30MM ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 827110

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R