BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø52 MM

    MDR report key: 17432378 · Received August 1, 2023

    Report

    Report Number
    3008021110-2023-00088
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 31, 2023
    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 MANUFACTURING CHARTS OF THE INVOLVED LOT #S 2226571, 1613496, 21AT2C8, NO PRE-EXISTING ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. THE EXPLANTED ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, PREOPERATIVE OR POST-OPERATIVE X-RAYS WERE REQUESTED BUT NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE FACTS: CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S 2226571, 1613496, 21AT2C8, NO PRE-EXISTING ANOMALIES WERE FOUND. THE SURGEON DOES NOT THINK THIS WAS RELATED TO THE IMPLANT. DURING THE REVISION THE HUMERUS FRACTURE WAS DISCOVERED AND REPAIRED. THE SURGEON DOES NOT ATTRIBUTE THE CAUSE TO BE THE IMPLANT. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS ANALYSIS: ACCORDING TO LIMACORPORATE PMS DATA, (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 WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    ON (B)(6), 2023, SHOULDER REVISION SURGERY WAS PERFORMED FOR A METAL BACK ANATOMIC IMPLANT THAT DISLODGED THE METAL BACK POLY LINER. THE SURGEON DOES NOT THINK THIS WAS RELATED TO THE IMPLANT. DURING THE REVISION A HUMERUS FRACTURE WAS DISCOVERED AND REPAIRED. THE SURGEON DOES NOT ATTRIBUTE THE CAUSE TO BE THE IMPLANT. SURGERY WAS SUCCESSFUL. PREVIOUS SURGERY (B)(6), 2023, PATIENT - MALE, DATE OF BIRTH - (B)(6), 1960. ITEMS EXPLANTED: SMR HUMERAL HEAD Ø52 MM, COMMERCIAL CODE 1322.09.520 - LOT #2226571 - STER. #2300028. SMR ECC.ADAPTOR TAPER STANDARD, COMMERCIAL CODE 1330.15.272 - LOT #1613496 - STER. #2100345. LINER F.MET.BACK GLEN.STANDARD, COMMERCIAL CODE 1377.50.010 - LOT #21AT2C8 - STER. #2200049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554248 SMR HUMERAL HEAD Ø52 MM SMR HUMERAL HEAD Ø52 MM KWT LIMACORPORATE S.P.A 1322.09.520 2226571

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention