BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø36MM SMALL-R

    MDR report key: 18570640 · Received January 24, 2024

    Report

    Report Number
    3008021110-2024-00009
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 15, 2024
    Report Date
    April 23, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K110598
    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 #1215372, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 20 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 19 OUT OF 20 GLENOSPHERES WITH LOT #1215372 AND STER. 1300050 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1210156, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 23 DEVICES MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, ALL 23 LINERS WITH LOT #1210156 AND STER. 1200327 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS: DEVICES INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2024 - AND A PICTURE OF THE EXPLANTS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS IS A NORMAL COURSE OF EVENTS. THE LINER OFTEN SHOWS SOME SIGNS OF WEAR AT THE INFERIOR PART DUE TO NOTCHING PHENOMENON, THAT WAS MORE FREQUENT IN THE EARLY YEARS WITHOUT THE USE OF LATERALIZATION, INFERIOR POSITIONING AND LARGER GLENOSPHERES. THE DISLOCATION IS NOT LINKED TO THAT, BUT PROBABLE HAPPENED DURING A FALL. THERE IS NO SIGN FOR IMPLANT RELATED FAILURE HERE". BASED ON INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOTS #1215372 AND #1210156. ACCORDING TO THE RECEIVED INFORMATION THE EXPLANTED REVERSE LINER SHOWED SOME WEAR MEDIALLY ONLY. ACCORDING TO THE MEDICAL CONSULTANT "THE LINER OFTEN SHOWS SOME SIGNS OF WEAR AT THE INFERIOR PART DUE TO NOTCHING PHENOMENON" AND "THE DISLOCATION. PROBABLE HAPPENED DURING A FALL. THERE IS NO SIGN FOR IMPLANT RELATED FAILURE HERE". WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESES DUE TO DISLOCATION IS 0.15%. 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.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOTS #1215372 AND #1210156, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 20 AND 23 DEVICES MANUFACTURED RESPECTIVELY. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOT #S. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2024, DUE TO DISLOCATION. THE FOLLOWING COMPONENTS GOT EXPLANTED: SMR GLENOSPHERE Ø36MM SMALL-R (PRODUCT CODE 1376.09.025, LOT #1215372 - STER. 1300050). SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.015, LOT #1210156 - STER. 1200327) - PRODUCT NOT SOLD IN THE US. IT WAS REPORTED THAT SOME WEAR WAS OBSERVED ON THE REVERSE LINER MEDIALLY ONLY. THE DEVICES WERE UPSIZED TO A 40MM GLENOSPHERE AND LATERALIZED LINER, ROTATED OF 90 DEGREES TO AVOID POSTERIOR DISLOCATION. PRIMARY SURGERY TOOK PLACE ON (B)(6), 2013. PATIENT IS A FEMALE, 81 YEARS OLD. NO FURTHER CLINICAL DATA IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION. THE FOLLOWING COMPONENTS GOT EXPLANTED: SMR GLENOSPHERE 36MM SMALL-R (PRODUCT CODE 1376.09.025, LOT #1215372 - STER. 1300050). SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.015, LOT #1210156 - STER. 1200327) - PRODUCT NOT SOLD IN THE US. IT WAS REPORTED THAT SOME WEAR WAS OBSERVED ON THE REVERSE LINER MEDIALLY ONLY. THE DEVICES WERE UPSIZED TO A 40MM GLENOSPHERE AND LATERALIZED LINER, ROTATED OF 90 DEGREES TO AVOID POSTERIOR DISLOCATION. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2013. PATIENT IS A FEMALE, 81 YEARS OLD. NO FURTHER CLINICAL DATA IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889514 SMR GLENOSPHERE Ø36MM SMALL-R ECCENTRICAL GLENOSPHERE - SMALL-R PHX LIMACORPORATE S.P.A. 1376.09.025 1215372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other