BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø50 MM

    MDR report key: 18683526 · Received February 12, 2024

    Report

    Report Number
    3008021110-2024-00013
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 17, 2024
    Report Date
    May 27, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2125924, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 62 DEVICES MANUFACTURED WITH THAT LOT #. ACCORDING TO OUR RECORDS, AT LEAST 37 OUT OF 62 HUMERAL HEADS WITH LOT #2125924 AND STER. 2200050 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: DEVICES INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE AND POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ASKED TO THE COMPLAINT SOURCE, BUT THEY WEREN'T AVAILABLE. 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 COMPONENTS MANUFACTURED WITH LOT #2125924, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF HUMERAL HEADS - BELONGING TO THE FAMILY CODES 1322.09.XXX - DUE TO DISLOCATION IS 0.10%. 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 FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2125924, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 62 DEVICES MANUFACTURED WITH THAT LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR HEMI PROSTHESIS PERFORMED ON (B)(6), 2024, DUE TO DISLOCATION OF THE SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #2125924 - STER.2200050). ACCORDING TO THE RECEIVED INFORMATION, THE HUMERAL HEAD DISLOCATED ON (B)(6), 2024. THE PATIENT HAD NOT FALLEN. THE FOLLOWING DEVICES WERE EXPLANTED: SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #2125924 - STER. 2200050). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #2320373 - STER. 2300222). SMR TRAUMA HUMERAL BODY # SHORT (PRODUCT CODE 1350.15.030, LOT #2304299 - STER. 2300095). THE DEVICES WERE REPLACED BY A 48MM HUMERAL HEAD, A SIZE MEDIUM TRAUMA HUMERAL BODY AND A STANDARD NEUTRAL ADAPTOR TAPER. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. PATIENT IS A MALE. EVENT HAPPENED IN JAPAN.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR HEMI PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION OF THE SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #2125924 - STER.2200050). THE HUMERAL BODY AND THE HUMERAL HEAD WERE REPLACED WITH NEW DEVICES. ACCORDING TO THE RECEIVED INFORMATION, THE HUMERAL HEAD DISLOCATED ON (B)(6) 2024. THE PATIENT HAD NOT FALLEN. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. PATIENT IS A MALE. EVENT HAPPENED IN JAPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087644 SMR HUMERAL HEAD Ø50 MM HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A. 1322.09.500 2125924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other