BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 12369998 · Received August 26, 2021

    Report

    Report Number
    3008021110-2021-00063
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    December 16, 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 STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO HQ FOR ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OP REVISION SURGERY. THE X-RAYS RECEIVED: DATED (B)(6) 2021: HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PREOP RADIOGRAPHS BEFORE FINAL REVISION SHOW A VERY HIGH IMPLANTED HUMERAL COMPONENT, IN OTHER WORDS THE RESECTION PLANE IS NOT CORRECT AND TOO HIGH. THIS LEADS TO INCREASED STRESS AND OVERLENGTHENING WHICH OFTEN RESULTS IN DISLOCATION. SO, THE REASON FOR THE FIRST DISLOCATION PROBABLY WAS A SURGICAL FAILURE, WHICH WAS ADDRESSED BY THE SHORT BODY (!) AND THE LATERALIZED HUMERAL LINER. THE SECOND REVISION, WHICH IS NOW RELEVANT CAN BE DUE TO INFECTION, BECAUSE THE SURGEON DESCRIBED FLUID, WHICH IS NOT NORMAL. DISLOCATION OFTEN CANNOT BE RESOLVED, IF SURGICAL ERRORS ARE UNDERLYING SUCH AS INCORRECT RESECTION PLANE, HUMERUS TORSION (SPECULATIVE) AND OTHER SOFT TISSUE PROBLEMS. I CANNOT SEE ANY IMPLANT-RELATED ISSUES HERE, ALL IS EITHER SURGICAL FAILURE OR INFECTION WHICH IS A FATEFUL COURSE OF EVENTS". CONSIDERING THAT: CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; ACCORDING TO THE MEDICAL CONSULTANT THERE WAS NO IMPLANT-RELATED ISSUE LEADING TO THE REVISION, BUT THE EVENT "IS EITHER SURGICAL FAILURE OR INFECTION WHICH IS A FATEFUL COURSE OF EVENTS"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS (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 PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO INFECTION AND IMPLANT DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330); SMR REVERSE HP LATERALIZED LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT #2017139 - STER. 2000330) - PRODUCT NOT MARKETED IN THE US. SMR FINNED STEM DIA.19MM - L.80 (PRODUCT CODE 1304.15.190, LOT #2101383 - STER. 2100068) SMR GLENOID #SMALL (PRODUCT CODE 1375.20.020, LOT #2018661 - STER. 2000360) - PRODUCT NOT MARKETED IN THE US. BONE SCREW DIA. 6.5MM - H. 20MM (PRODUCT CODE 8420.15.010, LOT #2103519 - STER. 2100078). BONE SCREW DIA. 6.5MM - H. 30MM (PRODUCT CODE 8420.15.030, LOT #2101695 - STER. 2100068). SMR CONNECTOR WITH SCREW (PRODUCT CODE 1374.15.310, LOT #2009063 - STER. 2000192) SMR REVERSE HP GLENOSPHERE DIA. 40MM (PRODUCT CODE 1374.50.400, LOT #2105830 - STER. 2100143); PRODUCT NOT MARKETED IN THE US AN ANTIBIOTIC CEMENT SPACER WAS INSERTED. IT WAS REPORTED THAT THERE WAS FLUID IN THE JOINT SPACE, AND SPECIMEN WAS TAKEN FOR ANALYSIS. NO INFORMATION IS AVAILABLE ON THE SPECIMEN ANALYSIS. ADDITIONALLY, ACCORDING TO THE REPORTED INFORMATION, THE ROTATOR CUFF WAS INSUFFICIENT. THE PROSTHESIS WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. THE FIRST REVISION SURGERY HAPPENED ON (B)(6) 2021, AND IT WAS DUE TO IMPLANT DISLOCATION. THE EVENT WAS REGISTERED AS COMPLAINT # (B)(4). PATIENT IS A MALE, 64 YEARS OLD. IT WAS REPORTED THAT PATIENT WAS A LEVEL 3 ACCORDING TO PHYSICAL STATUS CLASSIFICATION SYSTEM. HE IS OVERWEIGHT. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. 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 INFECTION AND IMPLANT DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330) · SMR REVERSE HP LATERALIZED LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT #2017139 - STER. 2000356) - PRODUCT MARKETED IN THE US AN ANTIBIOTIC CEMENT SPACER WAS INSERTED. IT WAS REPORTED THAT THERE WAS FLUID IN THE JOINT SPACE, AND SPECIMEN WAS TAKEN FOR ANALYSIS. ADDITIONALLY, ACCORDING TO THE REPORTED INFORMATION, THE ROTATOR CUFF WAS INSUFFICIENT. THE PROSTHESIS WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. THE FIRST REVISION SURGERY HAPPENED ON (B)(6) 2021 DUE TO IMPLANT DISLOCATION. PATIENT IS A MALE, 64 YEARS OLD. IT WAS REPORTED THAT PATIENT WAS A LEVEL 3 ACCORDING TO PHYSICAL STATUS CLASSIFICATION SYSTEM. HE IS OVERWEIGHT. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271810 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) KWS LIMACORPORATE S.P.A. 1352.15.005 2016929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other