BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD 44 MM

    MDR report key: 10572460 · Received September 23, 2020

    Report

    Report Number
    3008021110-2020-00070
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 23, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE LOT #1809666, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE 68 COMPONENTS MANUFACTURED WITH THIS LOT #. THEREFORE, ALL THE COMPONENTS WERE UP TO SPECIFICATION WHEN WERE PLACE ON THE MARKET. FIRST AND ONLY COMPLAINT RECEIVED ON 45 COMPONENTS ALREADY IMPLANTED WITH THIS LOT NUMBER. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER INVESTIGATION. XRAYS AND PATIENT DATA WERE NOT AVAILABLE. ACCORDING TO THE INFORMATION REPORTED BY THE COMPLAINT SOURCE, PATIENT EXPERIENCED CUFF FAILURE A FEW WEEKS POST PRIMARY SURGERY BECAUSE OF THE RIGOROUS PHYSIOTHERAPY. NO FURTHER INFORMATION WAS AVAILABLE TO INVESTIGATE THE ROOT CAUSE OF CUFF FAILURE DEEPER. IN CONCLUSION, CONSIDERING THAT NO ANOMALY WAS DETECTED BY THE CHECK OF THE MANUFACTURING CHART, THE LACK OF COMPLAINTS ON THE SAME LOT# AND THE INFORMATION REPORTED BY THE COMPLAINT SOURCE, WE CAN CONSIDER THIS CASE AS DUE TO HIGH LEVEL OF PHYSIOTHERAPY. EVENT NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, OCCURRENCE RATE OF CUFF FAILURE INVOLVING HUMERAL HEADS WITH PRODUCT CODE: (B)(4) IS (B)(4). MOST OF THESE CASES WERE JUDGED AS DUE TO PATIENT CONDITION. NO CORRECTIVE ACTIONS IMPLEMENTED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL KEEP THE MARKET MONITORED. PLEASE, CONSIDER THIS REPORT AS INITIAL-FINAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE INFORMATION REPORTED, THE OVER RIGOROUS PHYSIOTHERAPY WAS PROBABLE CAUSE FOR CUFF FAILURE. THE ANATOMIC IMPLANT WAS CONVERTED TO REVERSE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE: (B)(4), LOT# 1809666 - STER. 1800259); NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: (B)(4), LOT# 1911738 - STER. 1900318); SMR TRAUMA HUM. BODY # MEDIUM (PRODUCT CODE: (B)(4), LOT# 1908274 - STER. 1900242); LINER F. MET.BACK GLEN. SMALL-R (PRODUCT CODE: (B)(4), LOT# 19AT0H2 - STER. 1900214); 36 MM GLENOSPHERE, 36 MM REVERSE LINER, REVERSE HUMERAL BODY AND A SMALL-R CONNECTOR WERE IMPLANTED AS PER CONVERSION TO REVERSE. PRIMARY SURGERY PERFORMED ON (B)(6) 2020. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037556 SMR HUMERAL HEAD 44 MM SMR HUMERAL HEAD Ø44 MM (KWT, HSD) KWT LIMACORPORATE SPA 1322.09.440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention