BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM Ø18

    MDR report key: 9933139 · Received April 7, 2020

    Report

    Report Number
    3008021110-2020-00021
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    October 28, 2019
    Report Date
    April 6, 2020
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR CHECK: BY CHECKING THE MANUFACTURING CHART OF THE STEM 1304.15.180 LOT# 0904896, NO ANOMALY WAS FOUND ON 50 STEMS MANUFACTURED WITH THE SAME LOT#. MOREOVER, ACCORDING TO OUR RECORDS, AT LEAST 45 STEMS WITH THE SAME LOT# HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THEM. EXPLANTS ANALYSIS: THE EXPLANTED COMPONENTS WERE NOT RECEIVED BY LIMA CORPORATE, THUS NO DEEP INVESTIGATION CAN BE PERFORMED ON THEM. HOWEVER, SOME PICTURES WERE PROVIDED TO US: THE REVERSE LINER IS CLEARLY DAMAGED, IT SHOWS TWO "CUTS", WHICH WE BELIEVE OCCURRED INTRA-OP DUE TO THE TOOLS USED TO REMOVE THE COMPONENTS, AND NOT WHILE THE COMPONENT WAS STILL IMPLANTED. THIS HYPOTHESIS WAS ALSO CONFIRMED BY THE COMPLAINT SOURCE, WHO ALSO COMMENTED THAT THE DAMAGE MOST PROBABLY OCCURRED INTRA-OP. X-RAY ANALYSIS: LIMACORPORATE ONLY RECEIVED X-RAYS IMAGES DATED (B)(6) 2012, MORE RECENT IMAGES WERE NOT AVAILABLE. NEVERTHELESS, THESE IMAGES WERE SENT TO OUR MEDICAL EXPERT, WHO COMMENTED: "WHAT IS AVAILABLE TO ME IS A HISTORY OF INDEX SURGERY ON (B)(6) 2010 FOLLOWED BY REVISION (B)(6) 2011 XRAYS (B)(6) 2012 THEN REVISION 2019. THERE IS EVIDENCE OF AN OLD HEALED FRACTURE SITUATED AT THE TIP OF THE HUMERAL STEM WITH SOME DISPLACEMENT AND SLIGHT ANGULATION. WE DO NOT KNOW WHEN THIS FRACTURE OCCURRED AND IT WOULD BE PURE SPECULATION TO SUGGEST WITH THE INFORMATION AS TO WHEN IT OCCURRED. THAT SAID MY GUESS IS IT HAPPENED BETWEEN THE FIRST TWO SURGERIES? THE STEM IN 2012 LOOKS RADIOGRAPHICALLY LOOSE BUT CLINICALLY IT MAY BE SECURE? WITHOUT LATER RADIOGRAPHIC IMAGES OR MORE INFORMATION I AM UNABLE TO SUGGEST THE REASON FOR THE 2019 REVISION. I DO NOTE THE DAMAGE TO THE LINER BOTH ON THE ARTICULAR SIDE WHICH APPEARS MILD IMPINGEMENT WEAR? ON THE PROSTHESIS SIDE OF THE LINER THERE APPEAR TO BE PARTIAL "CUTS" IN THE EDGE OF THE LINER WHICH I SUSPECT ARE IN THE REGION OF THE CHAMFER? I AM UNABLE TO SUGGEST WHAT HAS CAUSED THIS. I AM SORRY BUT WITHOUT MORE INFORMATION AND OR MORE RECENT IMAGES (IMMEDIATELY BEFORE THE MOST RECENT SURGERY) I CANNOT HELP FURTHER." CONCLUSION: WITH THE VERY FEW INFORMATION AVAILABLE ON THIS CASE, NO DEFINITIVE CONCLUSION CAN BE DEFINED. BASED ON THE INFORMATION RECEIVED, THE REASON FOR THE PAIN EXPERIENCED BY THE PATIENT WAS RELATED TO A PREVIOUS BONE FRACTURE, BUT IT IS NOT KNOWN WHEN NOR WHY THIS FRACTURE OCCURRED. THE ONLY ADDITIONAL ANALYSIS WE COULD PERFORM, WAS THE CHECK OF THE DHRS, WHICH CONFIRMED THAT THE STEM HAD BEEN MANUFACTURED UP TO SPECIFICATIONS, NO DEVIATION DETECTED. THUS, AT THIS STAGE, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: ACCORDING TO OUR RECORDS, SPECIFIC REVISION RATE OF SMR CEMENTLESS FINNED STEMS L. 80 MM (CODES 1304.15.140÷130.15.240) RELATED TO PATIENT'S PAIN AND/OR BONE FRACTURE IS VERY LOW: 0.016% NO SPECIFIC ACTION FOR THIS CASE, LIMACORPORATE WILL KEEP THE MARKET MONITORED TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2011 (STEM WAS LEFT IN SITU), PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010. ACCORDING TO THE INFO RECEIVED, THE MAIN REASON FOR REVISION WAS PATIENT'S PAIN AND THE PAIN WAS RELATED TO A BONE FRACTURE OCCURRED YEARS PRIOR. THE CAUSE FOR THE FRACTURE IS NOT KNOWN. DURING THE REVISION SURGERY, THE METAL BACK GLENOID WAS LEFT IN SITU WHILE THE HUMERAL COMPONENTS, THE LINER, THE GLENOSPHERE AND THE SCREWS WERE REPLACED. PATIENT DATA: FEMALE, DOB (B)(6). EVENT HAPPENED IN (B)(6). NOTE: THE DELAY IN REPORTING THIS EVENT IS DUE TO AN UNCLEAR EVENT DESCRIPTION RECEIVED FROM THE COMPLAINT SOURCE: THE REVERSE LINER (CODE 1360.50.010, NOT REGISTERED IN THE USA) WAS INITIALLY APPOINTED AS SUSPECTED DEVICE, AS IT APPEARED THAT A DAMAGE TO THE LINER HAD OCCURRED. DURING THE INVESTIGATION, IT WAS FOUND OUT THAT THE MOST APPROPRIATE SUSPECTED DEVICE IS THE STEM (1304.15.180 LOT# 0904896), BECAUSE THE FRACTURE REPORTED REFERS TO THE HUMERAL BONE AND NOT TO THE LINER. IN ADDITION, BY ANALYZING THE PICTURES OF THE EXPLANTED COMPONENTS, TWO "CUTS" CAN BE NOTED ON THE LINER, WHICH ARE MOST PROBABLY RELATED TO THE USE OF THE TOOLS WHILE REMOVING IT AND NOT TO A BREAKAGE OCCURRED WHILE IT WAS IMPLANTED IN THE PATIENT. PLEASE CONSIDER THIS REPORT AS AN INITIAL-FINAL COMBINED MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396245 SMR CEMENTLESS FINNED STEM Ø18 SMR CEMENTLESS FINNED STEM Ø18 HSD LIMACORPORATE S.P.A. 1304.15.180 0904896

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention