BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22381176 · Received July 2, 2025

    Report

    Report Number
    3008021110-2025-00081
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390001410
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE PRODUCTS REMOVED IN THE REVISION SURGERY HEREBY REPORTED, NO PRE-EXISTING ANOMALY, THAT COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT, WAS FOUND OUT. THE MANUFACTURER WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE PRODUCTS REMOVED IN THE REVISION SURGERY HEREBY REPORTED, NO PRE-EXISTING ANOMALY, THAT COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT, WAS FOUND OUT. BASED ON THE RECORDS AVAILABLE, AT LEAST 43 OUT OF 62 ITEMS BELONGING TO THE PART CODE 1322.09.500, LOT NUMBER 2001533 AND STERILIZATION 2000135 HAVE BEEN IMPLANTED AND AT LEAST 20 OUT OF 32 ITEMS BELONGING TO THE PART CODE 1377.50.030, LOT NUMBER 18AT1J9 AND STERILIZATION 1800387 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT, SUCH AS X-RAYS OR PICTURES OF THE COMPONENTS EXPLANTED, THEREFORE WE ARE NOT ABLE TO CARRY OUT ANY FURTHER INVESTIGATION. HENCE, TAKING INTO ACCOUNT THAT: NO PRE-EXISTING ANOMALIES HAVE BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS BELONGING TO THE LOT NUMBERS 2001533 AND 18AT1J9. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) DUE TO CUFF FAILURE IS AROUND 0.51%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO ROTATOR CUFF FAILURE AND WEAR OF THE LINER PERFORMED ON (B)(6) 2025. PATIENT NEEDED A CONVERSION FROM AN ANATOMICAL IMPLANT TO A REVERSE CONFIGURATION. THE ROTATOR CUFF HAD FAILED. ADDITIONALLY, IT WAS FOUND THAT THE LINER HAD WORN DOWN IN ONE OF THE CORNERS. THE FOLLOWING DEVICES WERE REMOVED AND REPLACED BY REVERSE COMPONENTS: - SMR HUMERAL HEAD DIA. 50 MM (PART CODE 1322.09.500, LOT NUMBER 2001533, STERILIZATION (B)(4)). - SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 2002535, STERILIZATION (B)(4)). - LINER F. MET.BACK GLEN.LARGE (PART CODE 1377.50.030, LOT NUMBER 18AT1J9, STERILIZATION (B)(4)). - SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 2004189, STERILIZATION (B)(4)). PREVIOUS SURGERY PERFORMED ON (B)(6) 2020. THE FOLLOWING OTHER COMPONENTS WERE IMPLANTED DURING THE PREVIOUS SURGERY: - SMR METAL-BACK GLENOID LARGE (PART CODE 1375.21.030, LOT NUMBER 1906101, STERILIZATION (B)(4)). - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.210, LOT NUMBER 1922729, STERILIZATION (B)(4)). THE PATIENT IS A MALE, DATE OF BIRTH JANUARY 28TH, 1955. THE EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO ROTATOR CUFF FAILURE AND WEAR OF THE LINER PERFORMED ON MAY 19TH, 2025. PATIENT NEEDED A CONVERSION FROM AN ANATOMICAL IMPLANT TO A REVERSE CONFIGURATION. THE ROTATOR CUFF HAD FAILED. ADDITIONALLY, IT WAS FOUND THAT THE LINER HAD WORN DOWN IN ONE OF THE CORNERS. THE FOLLOWING DEVICES WERE REMOVED AND REPLACED BY REVERSE COMPONENTS: SMR HUMERAL HEAD DIA. 50 MM (PART CODE 1322.09.500, LOT NUMBER 2001533, STERILIZATION 2000135). SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT NUMBER 2002535, STERILIZATION 2000086) LINER F. MET.BACK GLEN.LARGE (PART CODE 1377.50.030, LOT NUMBER 18AT1J9, STERILIZATION 1800387) SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 2004189, STERILIZATION 2000129) PREVIOUS SURGERY PERFORMED ON AUGUST 14TH, 2020. THE FOLLOWING OTHER COMPONENTS WERE IMPLANTED DURING THE PREVIOUS SURGERY: SMR METAL-BACK GLENOID LARGE (PART CODE 1375.21.030, LOT NUMBER 1906101, STERILIZATION 1900242). SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.210, LOT NUMBER 1922729, STERILIZATION 2000042). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6)1955. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360468 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A. 1322.09.500 2001533 08033390001410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention