BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECCENT. GLENOSPHERE Ø 36MM

    MDR report key: 8964602 · Received September 5, 2019

    Report

    Report Number
    3008021110-2019-00096
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    July 26, 2019
    Report Date
    March 31, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHRS: BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON: A TOTAL OF 60 GLENOSPHERES CODE 1376.09.031 MANUFACTURED WITH LOT #1905433; A TOTAL OF 69 METAL BACKS CODE 1375.20.050 MANUFACTURED WITH LOT #1907684. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#S. EXPLANTS ANALYSIS: PICTURE OF THE EXPLANTS DO NOT SHOW ANY DAMAGE TO IMPLANTS THENSELVES. EXPLANTS WERE NOT RETURNED TO LIMACORPORATE FOR INVESTIGATION. XRAYS ANALYSIS: WE RECEIVED PRE-REVISION XRAYS (EXACT DATE UNKNOWN) AND SENT THEM TO MEDICAL CONSULTANT FOR A CLINICAL OPINION. FOLLOWING, HIS ANALYSIS IS REPORTED: "SURGICAL FACTOR VS PATIENT FACTOR AS TO THE CAUSE OF THE DISLOCATIONS. I DO NOT HAVE ENOUGH AND WHAT XRAYS THERE ARE POOR QUALITY BUT I WOULD SUGGEST THAT LATE SURGERY FOR MALUNION IS DIFFICULT AND HAS A HIGHER COMPLICATION RATE THAN IMMEDIATE SURGERY. ONE COULD ARGUE THAT THERE IS A "CLINICIAN FACTOR" (AT THIS POINT THE GENERAL PRACTITIONER) THAT IS CONTRIBUTORY. THERE IS A "PATIENT FACTOR" BECAUSE THE PROCEDURE IS MORE CHALLENGING. THERE IS A CLINICIAN FACTOR IN CHOICE OF REVISION IMPLANTS AND I SUSPECT ALSO BECAUSE THE VERY CHALLENGING RESTORATION OF STABILISING CUFF ELEMENTS WAS NOT ACHIEVED, BUT I STRESS THAT IS PURE SPECULATION! SO IT IS A MIX OF BOTH. PERHAPS SLIGHTLY MORE "CLINICIAN FACTOR THAN PATIENT" ACCORDING TO THE MEDICAL CONSULTANT, IT IS NOT POSSIBLE TO UNDERSTAND THE ROOT CAUSE OF THE EVENT. IN HIS OPINION, POSSIBLE CAUSE FOR DISLOCATION IS THE COMBINATION OF PATIENT AND CLINICIAN FACTOR RELATED TO THE COMPLEX PATIENT CONDITION. CONSIDERING THAT: CHECK OF DHRS FOUND THE IMPLANTS UP TO SPECIFICATIONS. NO FURTHER COMPLAINTS WERE RECEIVED ON THE INVOLVED LOT #S. THE MEDICAL EXPERT CONCLUDED THAT CAUSE FOR DISLOCATION WAS "A MIX OF PATIENT AND CLINICIAN FACTOR". WE CAN HYPOTHESIZE THAT ROOT CAUSE OF THE EVENT WAS DUE TO A COMBINATION OF PATIENT AND CLINICIAN FACTOR RELATED TO THE COMPLEX PATIENT CONDITION, AND JUDGE THE EVENT AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, OCCURRENCE RATE OF DISLOCATION OF SMR REVERSE IS 0.11%. MOST OF THESE CASE ARE PATIENT CONDITION/SURGICAL FACTOR RELATED. NO CORRECTIVE ACTIONS IMPLEMENTED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED.

    Description of Event or Problem · 0

    REVISION SURGERY OCCURRED ON THE (B)(6) 2019 DUE TO SHOULDER DISLOCATION. THIS WAS THE THIRD REVISION DUE TO DISLOCATION FOR THIS PATIENT, WHO SUFFERS OF POOR MUSCULAR HEALTH AND LACK OF STABILITY. FOLLOWING, CLINICAL HISTORY OF THE PATIENT IS REPORTED: IN 2018, HUMERAL HEAD FRACTURE MANAGED WITH NO SURGICAL INTERVENTION BY A GENERAL PRACTITIONER; DUE TO THIS POOR MANAGEMENT THERE WAS MALUNION OF THE HUMERAL HEAD; PRIMARY SURGERY PERFORMED ON THE (B)(6) 2019: THE PATIENT DISLOCATED ANTERIORLY WHILE ROLLING OVER IN BED IMMEDIATELY POST-SURGERY. REVISION WAS PERFORMED ON THE (B)(6) 2019 (#224/19, NOT REPORTED TO TGA BECAUSE DUE TO PATIENT CONDITION) PATIENT DISCLOCATED AGAIN ON THE (B)(6) 2019 (DAY 1 POST-REVISION) WHILE ROLLING OVER IN BED. SECOND REVISON PERFORMED ON THE (B)(6) 2019 (#230/19, NOT REPORTED TO FDA BECAUSE DUE TO PATIENT CONDITION); THIRD REVISION OCCURRED ON (B)(6) 2019(#274/19, CURRENT REPORT) FOR NO OBVIOUS REASONS. ACCORDING TO THE INFO REPORTED, PATIENT WAS ROLLING IN BED WHEN DISLOCATION OCCURRED. SURGEON COMMENTED THAT POORLY POSITIONED BASEPLATE RESULTED IN THE GLENOSPHERE SUPERIORLY INCLINATED, LEADING TO DISLOCATION. THE METALBACK AND GLENOSPHERE WERE REMOVED FROM THE PATIENT AND A CTA HEAD WAS IMPLANTED. THE HOLES IN THE GLENOID LEFT BY THE METALBACK PEG AND SCREWS WERE FILLED WITH BONE GRAFT. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE COMPONENTS INVOLVED, NO ANOMALY WAS FOUND ON A TOTAL OF 60 GLENOSPHERES CODE 1376.09.031 MANUFACTURED WITH LOT #1905433. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED ON THE (B)(6) 2019 DUE TO SHOULDER DISLOCATION. THIS WAS THE THIRD REVISION DUE TO DISLOCATION FOR THIS PATIENT, WHO SUFFERS OF POOR MUSCULAR HEALTH AND LACK OF STABILITY. FOLLOWING, IT IS REPORTED THE CLINICAL HISTORY OF THE PATIENT: IN 2018, HUMERAL HEAD FRACTURE MANAGED WITH NO SURGICAL INTERVENTION BY A GENERAL PRACTITIONER; DUE TO THIS POOR MANAGEMENT THERE WAS MALUNION OF THE HUMERAL HEAD; PRIMARY SURGERY PERFORMED ON THE (B)(6) 2019: THE PATIENT DISLOCATED ANTERIORLY WHILE ROLLING OVER IN BED IMMEDIATELY POST-SURGERY. REVISION WAS PERFORMED ON THE (B)(6) 2019 (#224/19, PRODUCTS INVOLVED NOT MARKED IN USA). PATIENT DISLOCATED AGAIN ON THE (B)(6) 2019 (DAY 1 POST-REVISION) WHILE ROLLING OVER IN BED. SECOND REVISION PERFORMED ON THE (B)(6) 2019 (#230/19, PRODUCTS INVOLVED NOT MARKED IN USA). THIRD REVISION OCCURRED ON (B)(6) 2019 (#274/19, CURRENT REPORT) FOR NO OBVIOUS REASONS. ACCORDING TO THE INFO REPORTED, PATIENT WAS ROLLING IN BED WHEN DISLOCATION OCCURRED. SURGEON COMMENTED THAT POORLY POSITIONED BASEPLATE RESULTED IN THE GLENOSPHERE SUPERIORLY INCLINED, LEADING TO DISLOCATION. THE METALBACK AND GLENOSPHERE WERE REMOVED FROM THE PATIENT AND A CTA HEAD WAS IMPLANTED. THE HOLES IN THE GLENOID LEFT BY THE METALBACK PEG AND SCREWS WERE FILLED WITH BONE GRAFT. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760670 SMR ECCENT. GLENOSPHERE Ø 36MM SMR ECCENTRIC GLENOSPHERE Ø 36MM (KWS, KWT, MBF, PHX) KWS LIMACORPORATE SPA 1376.09.031 1905433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention