BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 15649309 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00100
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 20, 2022
    Report Date
    February 15, 2023
    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

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THE SAME LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: THE ITEMS 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 13/09/2022 - AND PICTURES OF THE EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE EXPLANTS LOOK TO ME LIKE THERE IS RATHER ABRASION THAN BREAKAGE OF THE METALBACK GLENOID COMPONENT. THIS WOULD BE A SOMEWHAT NATURAL CAUSE OF EVENTS AFTER TSA AND 12 YEARS OF STANDING, THE PE (POLYETHYLENE) MIGHT HAVE WORN THIN DUE TO RC (ROTATOR CUFF) FAILURE AND THE SUBSEQUENT REVISION TO REVERSE WAS PART OF THIS PROCESS. THE SURGEON AT THE TIME OF THE FIRST REVISION ON (B)(6)2020, MUST HAVE MADE A COMMENT ABOUT THE METALBACK AT THE TIME, BECAUSE HE FELT IT TO BE SAVE TO LEAVE IT IN PLACE AND CONVERT TO RSA BY PUTTING A GLENOSPHERE ON IT. AT THE TIME OF THE SECOND REVISION ON (B)(6)2020, MUST HAVE MADE A COMMENT AS WELL, IF HE TOOK THE GLENOSPHERE OFF AND EXCHANGED IT, IF NOT, THIS MIGHT NOT HAVE BEEN VISIBLE. THIRD REVISION SURGERY PERFORMED ON (B)(6)2022, WAS DUE TO INFECTION AND CONSEQUENTLY ALL COMPONENTS WERE TAKEN OUT AS SUGGESTED BY EVIDENCE AND GUIDELINES. IN SUMMARY, THE "BROKEN" (IN MY OPINION RATHER ABRADED) GLENOID METALBACK IS JUST A COINCIDENCE HERE, AND NOT THE CAUSE FOR THIS REVISION. THE LAST REVISION (AND THE REVISIONS BEFORE) ARE NOT RELATED TO IT, THERE IS NO IMPLANT RELATED FAILURE HERE". THE SURGEON RESPONSIBLE FOR THE PREVIOUS TWO REVISIONS IS DIFFERENT FROM THE ONE WHO HAD OPERATING IN THE LATTER SURGERY. THE SURGEON REMARKS FROM PREVIOUS REVISION SURGERY STATE THAT THE FIXATION OF STEM AND GLENOID COMPONENTS WAS SATISFACTORY. ACCORDING TO THE RECEIVED INFORMATION, THE SURGEON WAS SATISFIED WITH IMPLANT'S FINAL STABILITY AFTER LINER EXCHANGE. THUS, NO COMMENT WAS REGISTERED ON THE METALBACK. CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; ACCORDING TO THE RECEIVED INFORMATION, DURING THE SURGERY THE BASEPLATE WAS FOUND TO HAVE SPLIT, BUT THE REASON OF THE BREAKAGE IS UNKNOWN; ACCORDING TO THE MEDICAL CONSULTANT, "THE "BROKEN" (IN MY OPINION RATHER ABRADED) GLENOID METALBACK IS JUST A COINCIDENCE HERE, AND NOT THE CAUSE FOR THIS REVISION. THE LAST REVISION (AND THE REVISIONS BEFORE) ARE NOT RELATED TO IT, THERE IS NO IMPLANT RELATED FAILURE HERE"; 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 INFECTION IS 0.08%. 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) 2022, DUE TO INFECTION. IT WAS REPORTED THAT THE BASEPLATE HAD SPLIT, AND THE PATIENT DEVELOPED INFECTION, PAIN AND LOSS OF RANGE OF MOTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1923280 - STER. 2000051). SMR CEMENTLESS FINNED STEM Ø23 (PRODUCT CODE 1304.15.230, LOT #1102716). SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1921914 - STER. 2000039). SMR REVERSE HP CORRECTION GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #2007618 - STER. 2000169) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #1303262 - STER. 1300160) - PRODUCT NOT SOLD IN THE US IT WAS REPORTED THAT SPECIMEN WAS TAKEN. A CEMENT SPACER WAS INSERTED INTO THE JOINT WHILE THE INFECTION IS TREATED. A CUSTOM PROSTHESIS IS THEN GOING TO BE IMPLANTED. ACCORDING TO THE RECEIVED INFORMATION, CLINICAL HISTORY OF PATIENT'S SHOULDER IS THE FOLLOWING: PRIMARY ANATOMIC TSA IMPLANTED APPROXIMATELY 12 YEARS AGO (EXACT DATE NOT KNOWN); FIRST REVISION SURGERY PERFORMED ON AUGUST 27TH, 2020. THE IMPLANT WAS CONVERTED TO REVERSE; SECOND REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO SUBLUXATION. THE EVENT WAS REGISTERED AS COMPLAINT #241_20; · THIRD REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION (HEREBY REPORTED). PATIENT IS A MALE, 70 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6)2022, DUE TO INFECTION. IT WAS REPORTED THAT THE BASEPLATE HAD SPLIT, AND THE PATIENT DEVELOPED INFECTION, PAIN AND LOSS OF RANGE OF MOTION. IT WAS REPORTED THAT THE REASON OF THE BREAKAGE OF THE BASEPLATE IS NOT KNOWN. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1923280 - STER. 2000051) SMR CEMENTLESS FINNED STEM Ø23 (PRODUCT CODE 1304.15.230, LOT #1102716) SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT #2005219 - STER. 2000192) - PRODUCT NOT SOLD IN THE US SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1921914 - STER. 2000039) SMR REVERSE HP CORRECTION GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #2007618 - STER. 2000169) - PRODUCT NOT SOLD IN THE US SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #1303262 - STER. 1300160) - PRODUCT NOT SOLD IN THE US IT WAS REPORTED THAT SPECIMEN WAS TAKEN, HOWEVER THE RESULTS ARE NOT AVAILABLE. A CEMENT SPACER WAS INSERTED INTO THE JOINT WHILE THE INFECTION IS TREATED. A CUSTOM PROSTHESIS IS THEN GOING TO BE IMPLANTED. ACCORDING TO THE RECEIVED INFORMATION, CLINICAL HISTORY OF PATIENT'S SHOULDER IS THE FOLLOWING: PRIMARY ANATOMIC TSA IMPLANTED APPROXIMATELY 12 YEARS AGO (EXACT DATE NOT KNOWN); FIRST REVISION SURGERY PERFORMED ON AUGUST 27TH, 2020. THE IMPLANT WAS CONVERTED TO REVERSE; SECOND REVISION SURGERY PERFORMED ON (B)(6)2020, DUE TO SUBLUXATION. THE EVENT WAS REGISTERED AS COMPLAINT #241_20; THIRD REVISION SURGERY PERFORMED ON (B)(6)2022, DUE TO INFECTION (HEREBY REPORTED). PATIENT IS A MALE, 70 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241675 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) KWS LIMACORPORATE S.P.A. 1352.15.005 1923280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention