BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 20448963 · Received October 15, 2024

    Report

    Report Number
    3008021110-2024-00088
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 9, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390001373
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT#: 1211144, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE (B)(4) DEVICES MANUFACTURED WITH THAT LOT#. DEVICE ANALYSIS: EXPLANTED COMPONENTS WERE NOT RETURNED TO LIMACORPORATE FOR INVESTIGATION. PICTURES OF THE EXPLANTED DEVICES WERE SHARED. IT IS VISIBLE THAT THE LINER HAS WORN OUT, HOWEVER THE COMPLAINT SOURCE DIDN'T REPORT ANY COMMENT ON IT. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE NOT ACCESSIBLE. BASED ON THE FEW INFORMATION RECEIVED WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT, HOWEVER CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT#: 1211144. IT IS UNKNOWN HOW LONG THE CUFF FAILED BEFORE THE SURGERY TOOK PLACE. THE SURVIVORSHIP OF THE PROSTHESIS IS OVER 10 YEARS. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED, RATHER IT WAS DUE TO THE PATIENT'S CONDITION. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) 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 TOTAL PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT#: 1211144 - STER. 1200305). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT#: 1305561 - STER. 1300219). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT#: 1309184 - STER. 1300279). LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT#: 1203963 - STER. 1200179). IT WAS REPORTED THAT WHILE LOOSENING THE PROXIMAL BODY FROM THE HUMERUS WITH THE OSTEOTOME, THE HUMERUS SUSTAINED A FRACTURE, WHICH WAS FIXATED WITH MULTIPLE FIBER WIRE SUTURES. THE COMPLAINT SOURCE CONFIRMED THAT THERE WASN'T ANY MALFUNCTION OF INSTRUMENTS. THE PROSTHESIS WAS CONVERTED TO REVERSE USING A 40MM GLENOSPHERE, A CONNECTOR WITH SCREW, A TRAUMA REVERSE BODY AND A SHORT 40MM LINER. MULTIPLE MICROBIOLOGY SPECIMENS WERE TAKEN, AND A THOROUGH WASHOUT OF THE WOUND WAS PERFORMED. IT IS UNKNOWN HOW LONG THE CUFF FAILED BEFORE THE SURGERY TOOK PLACE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2014. PATIENT IS A FEMALE, 71 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32603 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.42MM HSD LIMACORPORATE S.P.A. HUMERAL HEAD 1211144 08033390001373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other