BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 10682953 · Received October 15, 2020

    Report

    Report Number
    0001825034-2020-03814
    Event Type
    Injury
    Date Received
    October 15, 2020
    Report Date
    February 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMERBIOMET 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 DEVICES: ITEM#115370; LOT# 666100; COMP RVS TRAY CO 44MM; ITEM# XL-115363; LOT# 298700; ARCOM XL 44-36 STD HMRL BRNG; ITEM# 115310; LOT# 892640; COMP RVRS SHLDR GLNSP STD 36MM; ITEM# 12-113558; LOT# 224320; COMPR 8MM HUM FRACT STEM PPS; ITEM# 115396; LOT# 783340; COMP RVS CNTRL 6.5X30MM ST/RST; ITEM# 180552; LOT# 527240; COMP LK SCR 3.5HEX 4.75X25 ST; ITEM# 180552; LOT# 900780; COMP LK SCR 3.5HEX 4.75X25 ST; ITEM# 180550; LOT# 563630; COMP LK SCR 3.5HEX 4.75X15 ST. FOREIGN: EVENT OCCURRED IN (B)(6). 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: 0001825034-2020-03809, 0001825034-2020-03811, 0001825034-2020-03812, 0001825034-2020-03813, 0001825034-2020-03815, 0001825034-2020-03816, 0001825034-2020-03817, 0001825034-2020-03818. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT REVERSE SHOULDER PROCEDURE. SUBSEQUENTLY, THE PATIENT CLAIMS TO BE EXPERIENCING TINGLING, NUMBNESS, LOSS OF RANGE OF MOTION, TORN ROTATOR CUFF AND NERVE DAMAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147968 COMP RVRS 25MM BSPLT HA+ADPTR EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A 409640 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE