BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 14854124 · Received June 29, 2022

    Report

    Report Number
    3008021110-2022-00058
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 16, 2022
    Report Date
    November 2, 2022
    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 MANUFACTURING CHARTS OF THE INVOLVED LOT #1800915, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1800915, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 57 OUT OF 63 SMR REVERSE HUMERAL BODY SHORT WITH LOT NUMBER 1800915 AND STER. 1800055 HAVE BEEN IMPLANTED. EXPLANTS ANALYSIS AND FURTHER INFORMATION THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, IN PARTICULAR: - IF THE LIGHT POOL EXERCISES WERE ALLOWED ACCORDING TO THE REHAB PROGRAM. - THE REASON OF THE PREVIOUS REVISION SURGERIES. - THE DATE OF THE PRIMARY IMPLANT. - THE PATIENT'S CLINICAL HISTORY. THE COMPLAINT SOURCE REPORTED THE FOLLOWING INFORMATION: - THE LIGHT EXERCISE WAS WITHIN THE PATIENT'S REHAB PROGRAM. - THE PREVIOUS REVISION WAS OF A COMPETITOR'S SYSTEM. THE PATIENT HAD AN ANATOMICAL SHOULDER REPLACEMENT WHOSE ROTATOR CUFF HAD SUBSEQUENTLY FAILED AND RESULTED IN SIGNIFICANT BONE LOSS REQUIRING A REVERSE TOTAL REPLACEMENT. COMPETITOR'S SYSTEM EXPLANTED AND LIMA COMPONENTS WERE IMPLANTED DURING THIS REVISION. - THE PRIMARY SURGERY WAS DONE IN THE YEAR 2012 (THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN). X-RAYS ANALYSIS THE X-RAYS PROVIDED WERE SENT TO THE MEDICAL EXPERT, WHO STATED THAT "THE PROXIMAL HUMERUS ON THE PROVIDED RADIOGRAPHS SHOWS DEFICIENCY OF BONE (TUBERCULA), THE GLENOID BASEPLATE IS NOT ANGULATED INFERIORLY, THERE IS ALREADY A LONG LINER AT THE HUMERUS AND THE JOINT LINE IS PRETTY MUCH MEDIALIZED. ALL INDICATIONS FOR A PROBLEM WITH INSTABILITY FROM THE BEGINNING THAT PROBABLY HAS CONTRIBUTED TO THE PROBLEM. SO, THIS IS AN ISSUE OF THE PATIENT AND ITS CONDITIONS, NO SIGN FOR IMPLANT-RELATED FAILURE HERE". IN CONCLUSION: - THE CHECK OF THE DHR HIGHLIGHTS NO PRE-EXISTING ANOMALIES ON THE SMR REVERSE HUMERAL BODY SHORT WITH LOT NUMBER 1800915 AND STER. 1800055 - ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT HAD AN ANATOMICAL SHOULDER REPLACEMENT WHOSE ROTATOR CUFF HAD SUBSEQUENTLY FAILED AND RESULTED IN SIGNIFICANT BONE LOSS REQUIRING A REVERSE TOTAL REPLACEMENT - ACCORDING TO THE OPINION OF THE MEDICAL EXPERT, THE EVENT REPORTED IS ISSUE OF THE PATIENT AND ITS CONDITIONS AND THERE IS NO SIGN FOR IMPLANT-RELATED FAILURE. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO DISLOCATION TO BE 0,17%. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS 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 IMPLANT DISLOCATION. ACCORDING TO THE COMPLAINT SOURCE, PATIENT REPORTED INCIDENTS OF INSTABILITY (THE FIRST ONE DOING LIGHT EXERCISE IN A POOL). SINCE THEN, HE FELT PAIN, SUBLUXATION AND INSTABILITY IN ALL RANGES OF MOTION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1800915 - STER. 1800055). SMR REVERSE HP LATERALIZING LINER LONG (PRODUCT CODE 1362.09.120, LOT #2017138 - STR. 2100091) - PRODUCT NOT MARKETED IN THE US. PATIENT IS A MALE, 73 YEARS OLD. HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: PRIMARY SURGERY TOOK PLACE IN 2012 (EXACT DATE NOT KNOWN); FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO CUFF FAILURE. THE COMPETITOR'S ANATOMICAL SHOULDER WAS EXPLANTED AND THE SMR REVERSE LIMA PROSTHESIS WAS IMPLANTED; SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON JUNE 16TH, 2022, DUE TO IMPLANT DISLOCATION. ACCORDING TO THE COMPLAINT SOURCE, PATIENT REPORTED INCIDENTS OF INSTABILITY (THE FIRST ONE DOING LIGHT EXERCISE IN A POOL). SINCE THEN, HE FELT PAIN, SUBLUXATION AND INSTABILITY IN ALL RANGES OF MOTION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1800915 - STER. 1800055) · SMR REVERSE HP LATERALIZING LINER LONG (PRODUCT CODE 1362.09.120, LOT #2017138 - STER. 2100091) - PRODUCT NOT MARKETED IN THE US PATIENT IS A MALE, 73 YEARS OLD. HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: - PRIMARY SURGERY TOOK PLACE IN 2012 (EXACT DATE NOT KNOWN); - FIRST REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO CUFF FAILURE. THE COMPETITOR'S ANATOMICAL SHOULDER WAS EXPLANTED AND THE SMR REVERSE LIMA PROSTHESIS WAS IMPLANTED; - SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION (HEREBY REPORTED). EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923816 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) KWS LIMACORPORATE S.P.A. 1352.15.005 1800915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention