BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 23849594 · Received December 19, 2025

    Report

    Report Number
    3008021110-2025-00172
    Event Type
    Injury
    Date Received
    December 19, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390274234
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) WAS PERFORMED FOR ALL INVOLVED LOTS# AND STER. NUMBERS AND NO ANOMALIES WERE IDENTIFIED DURING PRODUCTION OR FINAL QUALITY CONTROL FOR THE COMPONENTS BELONGING TO THE LOTS LISTED ABOVE. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) WAS PERFORMED FOR ALL INVOLVED LOTS # AND STER. NUMBERS AND NO ANOMALIES WERE IDENTIFIED DURING PRODUCTION FOR THE COMPONENTS BELONGING TO THE LOTS LISTED ABOVE. DEVICE ANALYSIS. PHYSICAL ANALYSIS OF THE EXPLANTED COMPONENTS WAS NOT PERFORMED, AS THE DEVICES WERE NOT RETURNED TO LIMACORPORATE. IN THE ABSENCE OF RETURNED PARTS, IT IS NOT POSSIBLE TO ASSESS POTENTIAL MANUFACTURING DEFECTS, MATERIAL ANOMALIES, OR MECHANICAL DAMAGE. A MEDICAL EXPERT WAS CONSULTED AND PROVIDED THE FOLLOWING ASSESSMENT: "THE CASE IS A CLEAR EXAMPLE OF ROTATOR CUFF FAILURE WITH SUBSEQUENT ASEPTIC LOOSENING. RADIOGRAPHIC EVALUATION SHOWS OSTEOLYSIS AT THE PROXIMAL HUMERUS, CONSISTENT WITH THE PRESENCE OF METALLOTIC TISSUE OBSERVED INTRAOPERATIVELY. ROTATOR CUFF FAILURE LEADS TO DECENTERING OF THE HUMERAL HEAD, UPWARD MIGRATION, AND ECCENTRIC LOADING AND WEAR OF THE POLYETHYLENE LINER, AS DOCUMENTED IN THE EXPLANT PHOTOS. THE POLYETHYLENE PARTICLES CANNOT BE EFFECTIVELY CLEARED BY THE BODY, A PHENOMENON KNOWN AS "FRUSTRATED PHAGOCYTOSIS", WHICH ACTIVATES OSTEOCLASTS AND CAN RESULT IN PROGRESSIVE OSTEOLYSIS AND LOOSENING. THE 10-YEAR TIME INTERVAL TO REVISION IS CONSISTENT WITH THE EXPECTED AVERAGE TIME TO ROTATOR CUFF FAILURE IN THIS POPULATION AND FALLS WITHIN THE NORMAL RANGE. THERE ARE NO SIGNS OF IMPLANT RELATED FAILURE; THE OBSERVED OUTCOME APPEARS TO BE THE RESULT OF A PROGRESSIVE BIOLOGICAL AND BIOMECHANICAL COURSE RATHER THAN A DEVICE DEFECT." CONSIDERING THAT: THE REVIEW OF PRODUCTION AND STERILIZATION RECORDS DID NOT REVEAL ANY ANOMALIES FOR THE INVOLVED DEVICES; THE MEDICAL EXPERT ASSESSMENT ATTRIBUTES THE REVISION TO ROTATOR CUFF FAILURE AND SUBSEQUENT ASEPTIC LOOSENING, WITHOUT EVIDENCE OF IMPLANT RELATED DEFICIENCY; THE EVENT CANNOT BE CONSIDERED PRODUCT RELATED. PMS DATA. 55 SIMILAR EVENTS FROM (B)(4) UNITS SOLD WORLDWIDE (0,62%) IN THE PAST 3 YEARS. OVERALL REVISION RATE WW (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. PLEASE NOTE THIS IS THE FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) DUE TO CUFF FAILURE. THE METAL BACK GLENOID LINER (UNABLE TO MAKE OUT THE CODES), METAL BACK AND PROXIMAL HUMERAL COMPONENTS WERE REMOVED. THEN THE CONVERSION WAS PERFORMED. A SMALL REVERSE BODY, HEMI ADAPTOR AND CTA HEAD WAS PUT ONTO THE STEM WHICH WAS IN SITU. THE GLENOID CAVITY WAS BONE GRAFTED. PREVIOUS SURGERY WAS PERFORMED ABOUT END OF 2015. THE FOLLOWING SMR ANATOMICAL IMPLANTS WERE REMOVED: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE: 1322.09.460, LOT #: 1010166), SMR ECC. ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.274, LOT #: 1206128- STER. #: 1200202), SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT #: 1208151- STER. #: 1200281), SMR UNCEMENT. GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT #: 1303262 - STER. #1300160). THE PATIENT HAS AN HIGH BMI. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) DUE TO CUFF FAILURE. THE METAL BACK GLENOID LINER (UNABLE TO MAKE OUT THE CODES), METAL BACK AND PROXIMAL HUMERAL COMPONENTS WERE REMOVED. THEN THE CONVERSION WAS PERFORMED. A SMALL REVERSE BODY, HEMI ADAPTOR AND CTA HEAD WAS PUT ONTO THE STEM WHICH WAS IN SITU. THE GLENOID CAVITY WAS BONE GRAFTED. PREVIOUS SURGERY WAS PERFORMED ABOUT END OF 2015. THE FOLLOWING SMR ANATOMICAL IMPLANTS WERE REMOVED: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE: 1322.09.460, LOT #: 1010166) SMR ECC. ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.274, LOT #: 1206128- STER. #: 1200202) SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT #: 1208151- STER. #: 1200281) SMR UNCEMENT. GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT #: 1303262 - STER. #1300160) THE PATIENT HAS AN HIGH BMI. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243259 SMR SYSTEM SMR SYSTEM - HUMERAL HEAD DIA. 46 MM KWT LIMACORPORATE S.P.A 1322.09.460 08033390274234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other