BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CTA HUMERAL HEAD Ø46 MM

    MDR report key: 18854101 · Received March 7, 2024

    Report

    Report Number
    3008021110-2024-00023
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 6, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT #1110466, NO PRE-EXISTING ANOMALIES WERE FOUND ON DEVICES MANUFACTURED WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT #1110466. DEVICE ANALYSIS EXPLANTED COMPONENTS WERE NOT RETURNED TO LIMACORPORATE FOR INVESTIGATION. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE NOT ACCESSIBLE. BASED ON THE FEW INFORMATION RECEIVED WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT #1110466, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO OUR PMS DATA, THE REVISION RATE OF CTA HEADS - BELONGING TO THE FAMILY CODES 1323.07.XXX, 1323.09.XXX AND 1323.15.XXX - DUE TO CUFF FAILURE IS 0.11%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC HEMI IMPLANT PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE PROSTHESIS WAS CONVERTED TO REVERSE AND THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR CTA HUMERAL HEAD Ø46 MM (PRODUCT CODE 1323.09.460, LOT #1110466 - STER. 1700216) · SMR CTA HEADS ADAPTOR Ø36 MM (PRODUCT CODE 1352.15.200, LOT #C - STER. 1900263) PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT WAS FOR A TRAUMA REVERSE IN 2020 BUT THE GLENOID GOT FRACTURED UPON DRILLING, THEREFORE THE SMR ANATOMIC HEMI WAS IMPLANTED. NO PATIENT'S CLINICAL DETAILS ARE AVAILABLE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908260 SMR CTA HUMERAL HEAD Ø46 MM CTA HUMERAL HEADS (COCRMO) DIA.46MM KWS LIMACORPORATE S.P.A. 1323.09.460 1110466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other