BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø48 MM

    MDR report key: 18739506 · Received February 20, 2024

    Report

    Report Number
    3008021110-2024-00018
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    February 9, 2024
    Report Date
    February 15, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE DHRS OF THE INVOLVED LOT #1700565, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 64 DEVICES MANUFACTURED WITH THAT LOT #. DEVICE ANALYSIS: DEVICES INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS EVENT, SPECIFICALLY NO PRE-OPERATIVE X-RAYS WAS AVAILABLE FOR FURTHER INVESTIGATION OF THE ADVERSE EVENT. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #1700565, AND THAT THE SURVIVORSHIP OF THE PROSTHESIS IS OF 5 YEARS, WE CAN STATE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR HUMERAL HEADS - BELONGING TO PRODUCT CODE 1322.09.XXX - DUE TO CUFF FAILURE IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC HEMI PROSTHESIS THAT HAS TAKEN PLACE ON (B)(6) 2024, DUE TO CUFF FAILURE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE 1322.09.480, LOT #1700565 - STER. 1700092). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1811423 - STER. 1800266). SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT #1809688 - STER. 1800239). THE IMPLANT WAS EXCHANGED TO A SMR REVERSE PROSTHESIS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT'S CLINICAL DETAILS ARE UNKNOWN. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299450 SMR HUMERAL HEAD Ø48 MM HUMERAL HEADS (COCRMO) DIA.48MM KWT LIMACORPORATE S.P.A. 1322.09.480 1700565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention