BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 10MM MINI

    MDR report key: 8863975 · Received August 6, 2019

    Report

    Report Number
    0001825034-2019-03210
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    February 12, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED AS MEDICAL RECORDS CONFIRMED PAIN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF MEDICAL RECORDS IDENTIFIED A HISTORY OF SYNCOPAL FALLS, UNDERWEIGHT, AND MUSCLE TONE, AS A CONTRIBUTING FACTOR. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS. ITEM# 115370, LOT# 905390, COMP RVS TRAY CO 44MM; ITEM# XL-115363, LOT# 515590,  ARCOM XL 44-36 STD HMRL BRNG; ITEM# 115313, LOT# 855080, COMP RVSR SHLDR GLNSP +3 36MM; ITEM# 010000589, LOT# 047100, COMP RVRS 25MM BSPLT HA+ADPTR; ITEM# 115396, LOT# 957840, COMP RVS CNTRL 6.5X30MM ST/RST; ITEM# 180553, LOT# 107740, COMP LK SCR 3.5HEX 4.75X30 ST; ITEM# 180552, LOT# 480620, COMP LK SCR 3.5HEX 4.75X30 ST; ITEM# 180551, LOT# 046000, COMP LK SCR 3.5HEX 4.75X20 ST; ITEM# 180551, LOT# 358330, COMP LK SCR 3.5HEX 4.75X20 ST. 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: 0001825034-2019-03212, 0001825034-2019-03214, 0001825034-2019-03215, 0001825034-2019-03218. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY SHOULDER PROCEDURE. TWO YEARS POST SURGERY, IT WAS REPORTED THE PATIENT IS EXPERIENCING MODERATE PAIN WITH DECREASED FUNCTION. SUBSEQUENTLY, THE PATIENT WAS REFERRED TO PHYSICAL THERAPY WITH SLIGHT GAINS IN FUNCTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658112 COMP PRIMARY STEM 10MM MINI EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A 566180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other