BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22458124 · Received July 9, 2025

    Report

    Report Number
    3008021110-2025-00087
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 1, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390002004
    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 REMOVED COMPONENTS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THE DEVICES INVOLVED IN THIS EVENT. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE REMOVED COMPONENTS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THE DEVICES INVOLVED IN THIS EVENT. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBERS. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT, THEREFORE WE ARE UNABLE TO CARRY OUT FURTHER INVESTIGATION. HOWEVER, CONSIDERING THAT: NO PRE-EXISTING ANOMALIES HAVE BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS OF THE ITEMS INVOLVED IN THIS EVENT. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR ANATOMIC HUMERAL BODIES BELONGING TO THE FAMILY PRODUCT CODE 1350.15.XXX DUE TO LOOSENING IS LOWER THAN 0.01% BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT HAD A LIMA ANATOMIC REPLACEMENT AT UNKNOWN PRIOR DATE. DUE TO LOOSENING OF CEMENTED 3-PEGGED GLENOID COMPONENT, SIGNIFICANT OSTEOLYSIS OCCURRED. AFTER REMOVING THE GLENOID COMPONENT, A MIXTURE OF BONE GRAFT AND DEMINERALIZED BONE MATRIX WAS USED TO PACK THE DEFECT. THIS WAS THE SECOND STAGE IN THE TWO-STAGE REVISION PROCESS. THE FOLLOWING ANATOMIC BODY, HEAD AND ADAPTOR WERE REMOVED: - SMR HUMERAL HEAD Ø44 MM (PART CODE 1322.09.440, LOT NUMBER 1919684, STERILIZATION (B)(4)) - SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT UMBER 2023555, STERILIZATION (B)(4)). - SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 2023593, STERILIZATION (B)(4)). A REVERSE BODY AND PRIMA TT BASEPLATE WERE IMPLANTED INTO THE PREVIOUSLY GRAFTER GLENOID. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6)1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT HAD A LIMA ANATOMIC REPLACEMENT AT UNKNOWN PRIOR DATE. DUE TO LOOSENING OF CEMENTED 3-PEGGED GLENOID COMPONENT, SIGNIFICANT OSTEOLYSIS OCCURRED. AFTER REMOVING THE GLENOID COMPONENT, A MIXTURE OF BONE GRAFT AND DEMINERALIZED BONE MATRIX WAS USED TO PACK THE DEFECT. THIS WAS THE SECOND STAGE IN THE TWO-STAGE REVISION PROCESS. THE FOLLOWING ANATOMIC BODY, HEAD AND ADAPTOR WERE REMOVED: SMR HUMERAL HEAD Ø44 MM (PART CODE 1322.09.440, LOT NUMBER 1919684, STERILIZATION 2000024). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 2023555, STERILIZATION 2100038). SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 2023593, STERILIZATION 2100038). A REVERSE BODY AND PRIMA TT BASEPLATE WERE IMPLANTED INTO THE PREVIOUS GRAFTER GLENOID. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576405 SMR SHOULDER TRAUMA HUMERAL BODIES WITH LOCKING SCREW MEDIUM KWT LIMACORPORATE S.P.A. 1350.15.010 2023593 08033390002004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention