BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY

    MDR report key: 10885285 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00099
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    March 4, 2020
    Report Date
    November 20, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DEVICE HISTORY RECORDS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE OVERALL COMPONENTS THAT BELONG TO THE SAME LOT NUMBERS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOTS. EVEN IF REPEATEDLY REQUESTED, THE INFORMATION ON THE CAUSE OF THIS REVISION SURGERY WAS NOT PROVIDED, THE COMPLAINT SOURCE ONLY REPORTED THAT IT WAS DEFINITELY NOT RELATED TO THE DEVICES. FURTHERMORE, NO X-RAYS, NO PICTURES OF THE COMPONENTS, NO PATIENT'S DATA NOR ANY ADDITIONAL INFORMATION WAS PROVIDED. WITHOUT THE POSSIBILITY TO RECOVER ANY SPECIFIC INFORMATION ON THIS CASE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2020. THE CAUSES OF THE REVISION ARE UNKNOWN. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS THEN REVISED AGAIN ON (B)(6) 2020. THE SECOND REVISION SURGERY ((B)(6) 2020) WAS DUE TO INFECTION AND IT WAS REGISTERED AND REPORTED TO FDA AS COMPLAINT NUMBER (B)(4) (MFR REPORT 3008021110-2020-00098). DURING THE REVISION SURGERY OBJECT OF THIS REPORT, THE FOLLOWING COMPONENTS WERE EXPLANTED: - SMR REVERSE HUMERAL BODY PRODUCT CODE 1352.15.010 LOT#1916474 STER.1900372 - SMR REVERSE LINER +6 MM PRODUCT CODE 1360.50.820 LOT#16AT14M STER.1600339 - SMR GLENOSPHERE Ø 36MM PRODUCT CODE 1374.09.111 LOT#1901870 STER.1900051 - SMR SMALL-R CONNECTOR +2 PRODUCT CODE 1374.15.312 LOT#1919128 STER.1900396 - SMR METAL-BACK GLENOID SMALL R PRODUCT CODE 1375.21.005 LOT#1502512 STER.1500203 THIS EVENT OCCURRED IN USA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS DETECTED AND THE OVERALL COMPONENTS MANUFACTURED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOTS. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350740 SMR REVERSE HUMERAL BODY REVERSE HUMERAL BODY FOR ELECTIVE SURGERY KWS LIMACORPORATE SPA 1352.15.010 1916474

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention