BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 8468474 · Received April 1, 2019

    Report

    Report Number
    3008021110-2019-00035
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 14, 2019
    Report Date
    July 23, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE DHR OF THE INVOLVED LOT# NO PRE - EXISTING ANOMALIES FOUND - ON A TOTAL OF (B)(4) METAL BACK GLENOIDS MANUFACTURED WITH THE LOT# INVOLVED IN THIS REVISION CASE (COMPONENT NOT SOLD IN US); - ON A TOTAL OF (B)(4) HUMERAL BODIES MANUFACTURED WITH THE LOT# 1800915. PLEASE NOTE THAT OUR INVESTIGATION HAS BEEN FOCUSED ON THE METAL BACK GLENOID (EVENT IS A COMBINATION OF SURGICAL FACTOR AND PATIENT CONDITION). EVEN THE PMS DATA HAS BEEN STATISTICALLY EVALUATED BY CONSIDERING SOLD QUANTITY AND SIMILAR COMPLAINTS RECEIVED ON THIS COMPONENT (AGAIN, NOT MARKED IN USA). THE HUMERAL BODY (COMPONENT SOLD IN US AND REPLACED DURING THE REVISION SURGERY) WAS JUDGED AS NOT DIRECTLY INVOLVED AS SUSPECTED COMPONENT FOR THIS REVISION SURGERY. NO SPECIFIC ACTION FOR THIS CASE, LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE.

    Description of Event or Problem · 0

    LEFT SHOULDER REVISION SURGERY DUE TO LOOSENING OF METAL BACK GLENOID (NOT MARKED IN USA) OCCURRED ON THE (B)(6) 2019. PREVIOUS SURGERY ON THE (B)(6) 2018. THIS EVENT WAS REPORTED TO FDA BECAUSE ALSO THE REVERSE HUMERAL BODY #1352.15.005 LOT #1800915 WAS REPLACED. IT HAS BEEN REPORTED TO US THAT THIS PATIENT UNDERWENT SEVERAL REVISIONS SURGERY IN BOTH SHOULDERS AND SUFFERS OF POOR BONE QUALITY WITH DIAGNOSED OSTEOPOROSIS. THE SURGEON COMMENTED THAT PATIENT BONE QUALITY ON THE INFERIOR GLENOID BONE WAS POOR SO, DURING PREVIOUS SURGERY ((B)(6) 2018), IT WAS DECIDED FOR THE POSITIONING OF THE METAL BACK GLENOID (CODE 1375.20.020, NOT MARKED IN USA) A LITTLE HIGHER WHERE THE BONE WAS OF BETTER QUALITY AND ABLE TO SUPPORT IT. A 44 MM CORRECTION GLENOSPHERE WAS IMPLANTED TO DISTALISE THE ARTICULATION AND PROTECT THE INFERIOR GLENOID FROM SCAPULA NOTCHING. HOWEVER, THE METAL BACK BASEPLATE LOOSENED AND SHIFTED, REQUIRING SUBSEQUENT REVISION SURGERY (PERFORMED ON (B)(6) 2019, OBJECT OF THE CURRENT REPORT). DURING SURGERY ON (B)(6) 2019, ALL IMPLANTS WERE REMOVED AND A SMR L1 LONG PEG METAL BACK WAS IMPLANTED TO ADD EXTRA FIXATION FOR IMPLANT STABILITY. A CORRECTION GLENOSPHERE WITH SHORT LINER AND REPLACEMENT STEM AND BODY WERE IMPLANTED. THE SURGEON WAS SATISFIED WITH THE FINAL STABILITY. WE ARE AWARE THAT THIS PATIENT UNDERWENT AT LEAST A PREVIOUS SURGERY (ON THE RIGHT SHOULDER) RELATED TO ASEPTIC LOOSENING OF THE METAL BACK (MAY 17, 2018, LIMA COMPLAINT #(B)(4), NOT REPORTED TO FDA). ACCORDING TO OUR INVESTIGATION RESULTS, CONTRIBUTORY CAUSE FOR THE PREVIOUS RIGHT SHOULDER REVISION SURGERY WAS PATIENT'S BONE CONDITION (OSTEOARTHRITIS). EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE LOT#S OF THE COMPONENTS INVOLVED, NO ANOMALIES WERE FOUND. WE WILL SUBMIT A FINAL MDR AFTER FINAL INVESTIGATION.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE METAL BACK OCCURRED ON (B)(6) 2019. THIS WAS THE THIRD REVISION SURGERY FOR THE PATIENT: FIRST REVISION OCCURRED ON THE (B)(6) 2019 AND WAS DUE TO IMPLANT DISLOCATION, WHEREAS THE SECOND ONE OCCURRED ON THE (B)(6) 2018 AND WAS DUE TO IMPLANT LOOSENING. IT WAS REPORTED THAT PATIENT HAD POOR BONE QUALITY WITH DIAGNOSED OSTEOPOROSIS. THEREFORE, THE SURGEON PLANNED TO POSITION THE BASEPLATE A LITTLE HIGHER WHERE THE BONE WAS OF BETTER QUALITY AND ABLE TO SUPPORT A METAL BACK, BUT BASEPLATE SHIFTED REQUIRING SUBSEQUENT REVISION SURGERY. ALL THE FOLLOWING IMPLANTS HAVE BEEN REMOVED: SMR UNCEMENT. GLENOID # SMALL: CODE #1375.20.020, LOT #1810225, STER. #1800259; SMR REV. HP CORRECT. GLENOSPH. CODE #1374.50.444 LOT #1812224, STER. #1800258; SMR CONNECTOR SMALL STD: CODE #1374.15.310 LOT #1811609, STER. #1800246; SMR REVERSE HP LINER SHORT: CODE #1362.09.010 LOT #1802564, STER. #1800125; SMR REVERSE HUMERAL BODY SHORT: #1352.15.005 LOT #1800915, STER. #1800055; SMR CEMENTLESS FINNED STEM: #1304.15.140 LOT #1702313, STER. #1700110. AMONG THESE COMPONENTS, ONLY THE STEM, THE CONNECTOR AND THE REVERSE HUMERAL BODY ARE MARKETED IN THE U.S. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262979 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT KWS LIMACORPORATE SPA 1352.15.005 1800915

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention