BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22051074 · Received May 20, 2025

    Report

    Report Number
    3008021110-2025-00067
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390001410
    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 INVOLVED LOT #1511345, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES MANUFACTURED WITH THE SAME LOT #. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1511345, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 61 HUMERAL HEADS MANUFACTURED WITH THE SAME LOT #. DEVICE ANALYSIS: DEVICES INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE UNKNOWN - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE LAST REVISION WAS NECESSARY FOR RC FAILURE. THIS IS THE MOST COMMON CAUSE FOR ATSA REVISION AND A NATURAL COURSE OF EVENTS. THE CEMENTING OF THE LINER INTO THE METALBACK IS OFF-LABEL AND MAY HAVE CONTRIBUTED TO THE REASON FOR REVISION, BUT WE DON'T KNOW THAT. THIS IS A SURGICAL ISSUE. RADIOGRAPHS LOOK UNREMARKABLE, NOTED IS THE HIGH POSITION OF THE HUMERUS IN TERMS OF COR DUE TO THE RC FAILURE. THERE IS NO SIGN OF IMPLANT RELATED FAILURE HERE". CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #1511345. · ACCORDING TO THE MEDICAL EXPERT "THIS IS THE MOST COMMON CAUSE FOR ATSA REVISION AND A NATURAL COURSE OF EVENTS" AND "THERE IS NO SIGN OF IMPLANT RELATED FAILURE HERE". · THE PRIMARY SURGERY OF THE SMR TOTAL ANATOMIC PROSTHESIS WAS DONE IN 2013 AND IT WAS REVISED IN 2025, THEREFORE THE CUFF FAILURE OCCURRED 12 YEARS POST PRIMARY IMPLANT. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. 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 ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. NO TRAUMATIC EVENT REPORTED. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #1511345 - STER. 1700153) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1702177 - STER. 1700114) · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1211457 - STER. 1200358) · LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT #17AT1P5 - STER. 1700313) A 40MM ECCENTRIC GLENOSPHERE, STANDARD CONNECTOR, A SHORT PROXIMAL REVERSE HUMERAL BODY AND 40MM STANDARD VIT.E LINER WERE IMPLANTED. PATIENT IS A MALE, 53 YEARS OLD. HIS HISTORY OF SHOULDER HISTORY IS THE FOLLOWING: - PRIMARY SURGERY DONE ON (B)(6) 2013; - FIRST REVISION SURGERY ON (B)(6) 2018, DUE TO BREAKAGE OF THE LINER (EVENT REGISTERED AS COMPLAINT (B)(4); - SECOND REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE (HEREBY REPORTED). EVENT HAPPENED IN NEW ZEALAND.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. NO TRAUMATIC EVENT REPORTED. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #1511345 - STER. (B)(4)). · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1702177 - STER. (B)(4)). · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1211457 - STER. (B)(4)). · LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT #17AT1P5 - STER. (B)(4)). A 40MM ECCENTRIC GLENOSPHERE, STANDARD CONNECTOR, A SHORT PROXIMAL REVERSE HUMERAL BODY AND 40MM STANDARD VIT.E LINER WERE IMPLANTED. IT WAS REPORTED THAT DURING THE SURGERY, THE LINER WAS REMOVED WITH SOME DIFFICULTY, AS IT APPEARED THAT THE LINER HAD BEEN CEMENTED INTO THE METALBACK. IT TOOK TIME TO REMOVE THE BONE AND THE CEMENT. IT WAS NOTED BY THE SCRUB NURSE THAT CEMENT WAS FOUND BEHIND THE LINER. THE CEMENT WAS NOT FOUND ANYWHERE ELSE IN THE JOINT. THE METALBACK WAS WELL FIXED AND THE SURGEON HAD NO NEED TO EXPLANT. THE SURGEON DID EXPERIENCE DIFFICULTY SEATING / ENGAGING THE SAFETY SCREW FOR THE GLENOSPHERE. PATIENT IS A MALE, 53 YEARS OLD. HIS HISTORY OF SHOULDER HISTORY IS THE FOLLOWING: - PRIMARY SURGERY DONE ON (B)(6) 2013. - FIRST REVISION SURGERY ON (B)(6) 2018, DUE TO BREAKAGE OF THE LINER (EVENT REGISTERED AS COMPLAINT #(B)(4)). - SECOND REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE (HEREBY REPORTED). EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150107 SMR SHOULDER SMR SHOULDER - HUMERAL HEAD DIA.50 MM KWT LIMACORPORATE S.P.A. HUMERAL HEAD 1511345 08033390001410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other