BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 24108817 · Received January 19, 2026

    Report

    Report Number
    3008021110-2026-00031
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    December 15, 2025
    Report Date
    April 2, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390061230
    PMA / PMN Number
    K243826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHRS) OF INVOLVED LOT NUMBERS 2001378 AND 1810021 WERE CHECKED AND NO ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THESE LOT NUMBERS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT NUMBERS 2001378 AND 1810021. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHRS) FOR THE INVOLVED LOT NUMBERS 2001378 AND 1810021 WERE REVIEWED, AND NO ANOMALIES WERE IDENTIFIED IN THE COMPONENTS MANUFACTURED UNDER THESE LOT NUMBERS. THIS IS THE FIRST AND ONLY COMPLAINT REPORTED FOR LOT NUMBERS 2001378 AND 1810021. THE EXPLANT WAS LOST DURING SHIPMENT FROM THE HOSPITAL TO OUR SUBSIDIARY IN GREAT BRITAIN. THE COMPLAINT SOURCE PROVIDED SEVERAL X RAYS (PRE- AND POST - X-RAYS FROM PREVIOUS AN REVISION SURGERIES) AND PHOTOS OF THE EXPLANT, WHICH WERE FORWARDED TO A MEDICAL EXPERT FOR EVALUATION. BELOW IS HIS COMMENT ON THE CASE: "THE CASE IS A CLEAR SURGICAL PROBLEM. THE RADIOGRAPHS SHOW A MALPOSITIONED BASEPLATE WITH SUPERIOR ANGULATION INSTEAD OF DOWNWARD ANGULATION. ADDITIONALLY, THERE IS SEVERE MECHANICAL NOTCHING FROM THE BEGINNING. THE LONG LINER IS ANOTHER INDICATOR OF POOR SOFT TISSUE BALANCE. AS A RESULT, THERE IS SUPERIOR FORCE TO THE GLENOSPHERE THAT HAVE LED TO DISCONNECTION AND APPARENTLY FAILURE AND DESTRUCTION WITH METAL DEBRIS AS WELL. THERE IS NO SIGN FOR IMPLANT RELATED FAILURE, BUT THE IMPLANT FAILED BECAUSE OF SURGICAL MISTAKES. " IN CONCLUSION, BASED ON THE FACT THAT THE DHRS REVIEW DID NOT REVEAL ANY ANOMALIES, THIS IS THE FIRST AND ONLY COMPLAINT FOR THE INVOLVED LOT NUMBERS, THE EXPLANT WAS NOT RETURNED FOR ANALYSIS (LOST DURING TRANSPORT), AND THE MEDICAL EXPERT'S EVALUATION INDICATES THAT THE EVENT IS PRIMARILY DUE TO SURGICAL FACTORS, WE CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO PMS THE REVISION RATE DUE TO DISASSEMBLY AND/OR BREAKAGE OF REVERSE HP GLENOSPHERE (FAMILY CODE: 1374.50.XXX) IS NEARLY 0.004% . THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO POTENTIAL GLENOSPHERE LOOSE FROM MALE CONNECTOR IN GLENOID BASEPLATE. PATIENT STARTED TO HAVE MORE CLICKING AND PAIN IN SHOULDER 18 MONTHS PRIOR. THE SYMPTOMS WERE NOTICED OVER TIME AND NO SPECIFIC EVENT OR INJURY. PATIENT OTHERWISE FIT AND WELL. TWO PIECES OF METAL NOTED ON RECENT X-RAYS FROM GLENOSPHERE WIRE. GLENOSPHERE REVISED - MOST OF METAL WIRE REMOVED BUT NOT ALL. A SMALL FRAGMENT OF WIRE COULD NOT BE FOUND. PREVIOUS SURGERY PERFORMED ON (B)(6) 2020. THE EXPLANTED DEVICES: SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310, LOT: 1810021 - STER: (B)(4) , SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT: 2001378 - STER: (B)(4), SMR REVERSE HP LINER LONG (PRODUCT CODE: 1365.09.020, LOT: 1918642 - STER: (B)(4). PATIENT: MALE, 68 YEARS OLD, HEIGHT: 1.72M, WEIGHT: 82KG, OCCUPATION: DIVING, EVENT OCCURRED IN UNITED KINGDOM.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO POTENTIAL GLENOSPHERE LOOSE FROM MALE CONNECTOR IN GLENOID BASEPLATE. PATIENT STARTED TO HAVE MORE CLICKING AND PAIN IN SHOULDER 18 MONTHS PRIOR. THE SYMPTOMS WERE NOTICED OVER TIME AND NO SPECIFIC EVENT OR INJURY. PATIENT OTHERWISE FIT AND WELL. TWO PIECES OF METAL NOTED ON RECENT X-RAYS FROM GLENOSPHERE WIRE. GLENOSPHERE REVISED - MOST OF METAL WIRE REMOVED BUT NOT ALL. A SMALL FRAGMENT OF WIRE COULD NOT BE FOUND. PREVIOUS SURGERY PERFORMED ON (B)(6) 2020. THE EXPLANTED DEVICES: · SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310, LOT: 1810021 - STER: 1800219) · SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT: 2001378 - STER: 2000040) · SMR REVERSE HP LINER LONG (PRODUCT CODE: 1365.09.020, LOT: 1918642 - STER: 1900463) PATIENT: MALE, 68 YEARS OLD, HEIGHT: 1.72M, WEIGHT: 82KG, OCCUPATION: DIVING, EVENT OCCURRED IN UNITED KINGDOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169770 SMR SYSTEM SMR SYSTEM - REVERSE HP GLENOSPHERE DIA. 40MM PHX LIMACORPORATE S.P.A. 1374.50.400 2001378 08033390061230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention