BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 12114851 · Received July 5, 2021

    Report

    Report Number
    3008021110-2021-00053
    Event Type
    Injury
    Date Received
    July 5, 2021
    Date of Event
    June 24, 2021
    Report Date
    November 8, 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 LOT #2018574, 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 (B)(4) CEMENTLESS STEMS WITH LOT #2018574 AND STER. 2000351 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT #2021632, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 44 OUT OF (B)(4) REVERSE LINERS WITH LOT #2021632 - STER. 2100055 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT #2024176, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 37 OUT OF (B)(4) HUMERAL BODIES WITH LOT #2024176 - STER. 2100045 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. THE EXPLANTED DEVICES WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS DATED (B)(6) 2021 REFERRING TO PRE-OPERATIVE REVISION SURGERY OF (B)(6) 2021. LIMACORPORATE ALSO RECEIVED A TOTAL OF THREE X-RAYS - DATED (B)(6) 2021 - REFERRING TO PRE-OPERATIVE REVISION SURGERY OF (B)(6) 2021. ADDITIONALLY, ONE X-RAYS OF THE ORIGINAL HEMI IMPLANT WAS PROVIDED - EXACT DATE NOT KNOWN. ALL AVAILABLE X-RAYS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING THE MEDICAL CONSULTANT COMMENTS: "FIRST COMMENTS TO MAKE IS AS BEST I CAN TELL THE BASEPLATE IS WELL POSITIONED WITH THE INFERIOR PORTION ALMOST AT THE INFERIOR MARGIN OF THE NATIVE GLENOID. THE TILT IS SLIGHTLY DOWN WHICH IS GOOD. I CANNOT COMMENT ON THE VERSION OF THE HUMERUS BECAUSE THAT IS NOT POSSIBLE ON XRAY. I CANNOT SEE ANY EVIDENCE OF INFERIOR IMPINGEMENT WHICH IS ALSO GOOD BUT DOES NOT EXCLUDE ANTERIOR OR POSTERIOR IMPINGEMENT. IN SUMMARY THE BASEPLATE AND THE HUMERAL COMPONENTS "LOOK SATISFACTORY". I CAN SEE THE ORIGINAL IMPLANT BUT IT DOES NOT APPEAR TO BE CONNECTED TO THE HUMERUS AND POSSIBLY WITH A LATERAL VIEW WE MIGHT SEE IT IS COMPLETELY DETACHED. THE SURGEON WOULD KNOW BUT DOES NOT RECORD THIS. THE SIGNIFICANCE BEING THE HUMERUS WOULD HAVE MIGRATED SUPERIORLY WITH ASSOCIATED CONTRACTURE OF THE SOFT TISSUES MAKING REDUCTION DIFFICULT AS THE SURGEON EXPERIENCED AND NECESSITATING SHORTENING OF THE HUMERUS. THE INITIAL COMPONENTS WERE AS I UNDERSTAND 44MM GLENOSPHERE BUT IT DOES NOT SPECIFY CONCENTRIC OR ECCENTRIC. THIS DISLOCATED AND THE 2ND REVISION IF I UNDERSTAND CORRECTLY WAS TO REIMPLANT THE SAME SIZED COMPONENTS BUT CHANGE THE THE ROTATION OF THE GLENOSPHERE TO ANTERIOR. I DON'T THINK I WOULD HAVE DONE THAT BUT TRIALLED A LATERALISING HUMERAL IMPLANT. THE LOGIC OF REVISING THIS COMBINATION TO A 36 MM AND RETENTIVE LINER WAS NOT A GOOD OPTION AS PREDICTABLY THIS ALSO DISLOCATED. IT IS NOT MENTIONED BUT SOMETIMES SCARRING INFERIORLY CAN ACT AS A FULCRUM AND BE RESPONSIBLE FOR THE INSTABILITY. IT IS RISKY SURGERY TO DEAL WITH THAT BUT NECESSARY IF PRESENT. I AGREE THIS WAS A DIFFICULT PROBLEM TO DEAL WITH AND THE LOSS OF THE STABILISING ANTERIOR AND POSTERIOR CUFF ATTACHMENTS WILL HAVE SIGNIFICANTLY MADE THE INSTABILITY GREATER". IN CONCLUSION, ACCORDING TO THE MEDICAL EXPERT "[...] A DIFFICULT PROBLEM TO DEAL WITH. I AM CONCERNED ABOUT COMPONENT CHOICES, AND I THINK ASKING ADVICE WOULD HAVE BEEN APPROPRIATE. THAT MAY HAVE HAPPENED? WE DON'T KNOW. IN CONCLUSION I THINK WE HAVE TO SHARE THE REASON FOR FAILURE PARTLY SURGEON BUT PROBABLY MOSTLY PATIENT CAUSE. IT IS NOT "PROSTHESIS" CAUSE!". BASED ON THE PERFORMED ANALYSIS, AND CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2018574, #2021632 AND #2024176; ACCORDING TO THE MEDICAL EXPERT, THE REASON FOR FAILURE IS PARTLY SURGEON- AND MOSTLY PATIENT-RELATED; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: (B)(4). 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 IMPLANT PERFORMED ON (B)(6) 2021, DUE TO DISLOCATION. ACCORDING TO THE RECEIVED INFORMATION, SURGEON PLANNED AN OPEN REDUCTION. HOWEVER, IT WAS REPORTED THAT THE IMPLANT WAS STILL UNSTABLE AS BALANCING THE TISSUE WAS PROBLEMATIC DUE TO PATIENT'S SURGICAL HISTORY OF TRAUMA AND AGE. ACCORDING TO THE COMPLAINT SOURCE, THE HUMERUS WAS REQUIRED TO BE SHORTENED, THUS ALL HUMERAL COMPONENTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.150, LOT #2018574 - STER. 2000351). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2024176 - STER. 2100045). SMR REVERSE HP LINER SHORT (PRODUCT CODE 1362.09.010, LOT #2021632 - STER. 2100055) - PRODUCT NOT MARKETED IN THE US NEW COMPONENTS WERE IMPLANTED. PATIENT'S REVISION HISTORY IS THE FOLLOWING: PRIMARY IMPLANT OF COMPETITOR'S HEMI PROSTHESIS (EXACT DATE NOT KNOWN). FIRST REVISION SURGERY ON (B)(6) 2021, DUE TO PATIENT'S FALL. COMPETITOR'S HEMI PROSTHESIS WAS EXPLANTED AND A SMR REVERSE IMPLANT WAS PLACED IN WE GOT AWARE THAT THE SAME PATIENT UNDERWENT TWO OTHER SUBSEQUENT SURGERIES: ON (B)(6) 2021, REVISION DUE TO DISLOCATION. EVENT REGISTERED AS COMPLAINT #161_21 ON (B)(6) 2021, REVISION DUE TO DISLOCATION. EVENT REGISTERED AS (B)(4) AND REPORTED TO THE FDA AS MFR 3008021110-2021-00056. PATIENT IS A FEMALE, 92 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #2018574, #2024176 AND #2021632, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAIN 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 IMPLANT PERFORMED ON (B)(6) 2021, DUE TO DISLOCATION. ACCORDING TO THE RECEIVED INFORMATION, SURGEON PLANNED AN OPEN REDUCTION. HOWEVER, IT WAS REPORTED THAT THE IMPLANT WAS STILL UNSTABLE AS BALANCING THE TISSUE WAS PROBLEMATIC DUE TO PATIENT'S SURGICAL HISTORY OF TRAUMA AND AGE. ACCORDING TO THE COMPLAINT SOURCE, THE HUMERUS WAS REQUIRED TO BE SHORTENED, THUS ALL HUMERAL COMPONENTS WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.150, LOT #2018574 - STER. 2000351). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2024176 - STER. 2100045). SMR REVERSE HP LINER SHORT (PRODUCT CODE 1362.09.010, LOT #2021632 - STER. 2100055) - PRODUCT NOT MARKETED IN THE US. NEW COMPONENTS WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021 (REVISION OF COMPETITOR'S RESURFACING HEMI IMPLANT DUE TO A FALL). PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012878 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) KWS LIMACORPORATE S.P.A. 1352.15.005 2024176

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other