BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø44 MM

    MDR report key: 16944807 · Received May 17, 2023

    Report

    Report Number
    3008021110-2023-00062
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 24, 2023
    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#: 1817490, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) DEVICES MANUFACTURED WITH THE SAME LOT#. THE INVOLVED BATCH WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WEREN'T AVAILABLE. BASED ON THE INFORMATION RECEIVED AND CONSIDERING THAT CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #1817490, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF HEMI PROSTHESIS 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 WILL CONTINUE 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 #1817490, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 68 COMPONENTS MANUFACTURED WITH THAT LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR HEMI PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO CUFF FAILURE. IT WAS CONFIRMED BY THE COMPLAINT SOURCE THAT THE CUFF WAS IN GOOD CONDITION WHEN THE PRIMARY IMPLANT WAS DONE, HOWEVER IT SUBSEQUENTLY FAILED WITH TIME, AND HENCE THE NEED FOR A REVISION SURGERY TO CONVERT THE PROSTHESIS TO REVERSE. THE FOLLOWING COMPONENTS GOT EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE: 1322.09.440, LOT#: 1817490 - STER. 1800388). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.270, LOT#:1812038 - STER. 1800283). SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE: 1350.15.010, LOT#:1809688 - STER. 1800239). THE PROSTHESIS WAS CONVERTED TO SMR REVERSE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A FEMALE, 52 YEARS OLD. EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR HEMI PROSTHESIS PERFORMED ON MAY 5TH, 2023, DUE TO CUFF FAILURE. THE FOLLOWING COMPONENTS GOT EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT #1817490 - STER. 1800388) NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1812038 - STER. 1800283) SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT #1809688 - STER. 1800239) THE PROSTHESIS WAS CONVERTED TO SMR REVERSE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A FEMALE, 52 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603191 SMR HUMERAL HEAD Ø44 MM HUMERAL HEADS (COCRMO) DIA.44MM KWT LIMACORPORATE S.P.A. 1322.09.440 1817490

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention