BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø36 MM

    MDR report key: 12370024 · Received August 26, 2021

    Report

    Report Number
    3008021110-2021-00067
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    August 12, 2021
    Report Date
    December 22, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1007099, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 28 OUT OF 40M GLENOSPHERES WITH LOT # 1007099 - STER. 1000190 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1007272, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 87 OUT OF 95 REVERSE LINERS WITH LOT #1007272 - STER. 1000263 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR ANALYSIS. X-RAYS: LIMACORPORATE RECEIVED A TOTAL OF ONE X-RAY AND ONE CT SCAN REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY AND CT SCAN RECEIVED - DATED (B)(6) 2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE ONE XRAY IS AN ANTERIOR SHOULDER GIRDLE XRAY WHICH SHOWS THE GLENOHUMERAL COMPONENTS OBLIQUELY AND IT IS DIFFICULT TO MAKE AN ABSOLUTE ANALYSIS. THE CT SCAN DOESN'T HELP MUCH, SUFFICE TO SAY THERE ISN'T OBVIOUS LYSIS AROUND THE BASEPLATE, BUT AGAIN THE IMAGE IS POOR QUALITY. SO. GUESSING, THE IMPRESSION I HAVE IS THE GLENOID COMPONENT LOOKS VERY HIGH AND THIS WOULD FIT WITH THE SEEN WEAR ON THE POLYETHYLENE IMPLANT INDICATING IMPINGEMENT. [...] THE CHAMFERED PORTION WAS SUPERIOR RATHER THAN THE DESIGNED POSITION INFERIORLY WHICH IS TO MITIGATE AGAINST IMPINGEMENT). THIS POSITION OF THE LINER WAS COMMONLY USED IF THERE WERE CONCERNS RE INSTABILITY AND MANY SURGEONS ROUTINELY INSERTED THE LINER "UPSIDE DOWN". THERE IS A SUGGESTION OF LYSIS AT THE JUNCTION OF THE INFERIOR SMOOTH PORTION AND THE INGROWTH PORTION OF THE HUMERAL STEM THAT COULD BE CONSISTENT WITH INFECTION. THE BIGGEST CONCERN IS THE HISTORY OF INCREASING PAIN AFTER PRESUMABLY ALMOST 10 YEARS OF "COMFORT" WHICH IS HIGHLY SUGGESTIVE OF INFECTION IN THE ABSENCE OF OTHER OBVIOUS CAUSES. THE IMPINGEMENT AND POLY WEAR GENERALLY DOESN'T CAUSE PAIN AND SO I AM NOT CONVINCED ABOUT THE SURGEON'S PROPOSAL AS TO THE CAUSE OF THE PAIN. I ASSUME GIVEN THAT THE SURGEON WAS THINKING OF INFECTION THAT APPROPRIATE SAMPLES WERE TAKEN? IN SUMMARY THE ORIGINAL SURGERY HAD THE BASEPLATE TOO HIGH AND THERE WAS IMPINGEMENT. THE ABNORMAL POSITIONING OF THE LINER I DO NOT THINK IS OF GREAT CONSEQUENCE. IF THERE IS NO INFECTION PRESENT, THEN THE PATIENT CAN REASONABLY EXPECT A SATISFACTORY OUTCOME. IF INFECTION IS PRESENT, IT WILL MANIFEST SOON". CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1007099 AND #1007272; · ACCORDING TO THE MEDICAL CONSULTANT "THE ORIGINAL SURGERY HAD THE BASEPLATE TOO HIGH AND THERE WAS IMPINGEMENT. THE ABNORMAL POSITIONING OF THE LINER I DO NOT THINK IS OF GREAT CONSEQUENCE. IF THERE IS NO INFECTION PRESENT, THEN THE PATIENT CAN REASONABLY EXPECT A SATISFACTORY OUTCOME. IF INFECTION IS PRESENT, IT WILL MANIFEST SOON"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO PAIN IS 0.02%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE 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 REVERSE PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO PAIN. ACCORDING TO THE COMPLAINT SOURCE, PATIENT WAS EXPERIENCING ONGOING PAIN THAT HAS INCREASED OVER A PERIOD OF SEVERAL MONTHS. UPON REMOVAL OF THE 36MM HUMERAL LINER, IT WAS REPORTED THAT THE LINER WAS FOUND TO HAVE THE CHAMFERED SIDE FACING ANTERIORLY, RESULTING IN SIGNIFICANT WEAR ON ITS POSTERIOR SIDE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOSPHERE Ø36 MM (PRODUCT CODE 1374.09.110, LOT #1007099 - STER. 1000190). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #1007272 - STER. 1000263) - PRODUCT NOT MARKETED IN THE US. A 44MM CORRECTION GLENOSPHERE AND A SHORT 44MM LINER WERE IMPLANTED. THE METAL BACK WAS ASSESSED AND FOUND STABLE. IT WAS REPORTED THAT ACCORDING TO THE SURGEON RESPONSIBLE FOR THE REVISION, THE PAIN MAY BE ATTRIBUTED TO THE GLENOSPHERE WEARING UPON THE LINER. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2011. THE SURGEON RESPONSIBLE FOR THE REVISION WAS DIFFERENT FROM THE SURGEON WHO OPERATED THE PRIMARY SURGERY. PATIENT IS A FEMALE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO PAIN. ACCORDING TO THE COMPLAINT SOURCE, PATIENT WAS EXPERIENCING ONGOING PAIN THAT HAS INCREASED OVER A PERIOD OF SEVERAL MONTHS. UPON REMOVAL OF THE 36MM HUMERAL LINER, IT WAS REPORTED THAT THE LINER WAS FOUND TO HAVE THE CHAMFERED SIDE FACING ANTERIORLY, RESULTING IN SIGNIFICANT WEAR ON ITS POSTERIOR SIDE. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOSPHERE Ø36 MM (PRODUCT CODE 1374.09.110, LOT # 1007099 - STER. 1000190). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT # 1007272 - STER. 1000263) - PRODUCT NOT MARKETED IN THE US. A 44MM CORRECTION GLENOSPHERE AND A SHORT 44MM LINER WERE IMPLANTED. THE METAL BACK WAS ASSESSED AND FOUND STABLE. IT WAS REPORTED THAT ACCORDING TO THE SURGEON RESPONSIBLE FOR THE REVISION, THE PAIN MAY BE ATTRIBUTED TO THE GLENOSPHERE WEARING UPON THE LINER. ORIGINAL SURGERY DONE ON (B)(6) 2011. SURGEON RESPONSIBLE FOR THE REVISION IS DIFFERENT FROM THE SURGEON WHO OPERATED THE PRIMARY SURGERY. PATIENT IS A FEMALE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267929 SMR GLENOSPHERE Ø36 MM GLENOSPHERE KWS LIMACORPORATE S.P.A. 1374.09.110 1007099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other