BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø54 MM

    MDR report key: 9310021 · Received November 12, 2019

    Report

    Report Number
    3008021110-2019-00126
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    November 3, 2019
    Report Date
    May 25, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHART OF THE SMR HUMERAL HEAD INVOLVED (LOT# 0902772) NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. WE RECEIVED SOME PICTURES OF THE EXPLANTS AND SOME PRE-OP REVISION SURGERY X-RAYS (EXACT DATE UNKNOWN). FOLLOWING, THE LIMA MEDICAL CONSULTANT OPINION ON THE CASE BASED ON THE INFO RECEIVED: "THE X-RAY IMAGE ALTHOUGH AN OBLIQUE VIEW OF THE GLENO-HUMERAL JOINT SHOWS THE POSITION AND INCLINATION OF THE GLENOID COMPONENT TO BE SATISFACTORY. I CANNOT COMMENT ON THE HUMERAL HEAD SIZE AND RELATIONSHIP TO THE TUBEROSITIES BECAUSE THAT DETAIL IS OBSCURED. I NOTE YOUR COMMENT THAT THE ARTICULAR SURFACE OF THE POLYETHYLENE SHOWED SOME WEAR BUT IT IS NOT SPECIFIED SO I CANNOT MAKE CONCLUSIONS IN THAT REGARD. THERE IS A SUGGESTION OF LYSIS PARTICULARLY AROUND THE INFERIOR HALF OF THE METAL BACK GLENOID BUT THE IMPLANT HAS NOT OBVIOUSLY MIGRATED. THE IMAGES OF THE EXPLANTS ARE LARGELY UNREMARKABLE APART FROM SOME SLIGHT WEAR ON THE ARTICULAR SURFACE OF THE POLYETHYLENE LINER WHICH IS PARTLY OBSCURED BY THE FINGERS OF THE PERSON HOLDING IT. THE HUMERAL HEAD IS DISLOCATED POSTERIORLY SO IT RAISES THE POSSIBILITY OF POSTERIOR CUFF FAILURE AS THE CAUSE OF THIS "LATE STAGE" DISLOCATION. I TRUST THIS IS OF ASSISTANCE". BASED ON THE ANALYSIS PERFORMED (MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS) AND ON THE MEDICAL JUDGMENT RECEIVED, WE CAN SPECULATE THAT DISLOCATION CAN BE LINKED TO THE POSSIBILITY OF POSTERIOR CUFF FAILURE (PATIENT PATHOLOGY PROGRESSION RELATED). CASE NOT PRODUCT RELATED. PMS DATA BY CONSIDERING: THE TOTAL NUMBER OF REVISION SURGERIES LIMA RECEIVED ABOUT IMPLANT DISLOCATION RELATED TO ROTATOR CUFF FAILURE; THE TOTAL NUMBER OF SMR ANATOMIC PROSTHESIS SOLD WW ((B)(4) WE CAN ESTIMATE A SPECIFIC REVISION RATE OF (B)(4). ACCORDING TO OUR DATA, EVENTS WERE PATIENT AND/OR SURGICAL FACTOR RELATED. ACCORDING TO THE COMPLAINTS INVESTIGATED, NONE OF THE EVENTS REPORTED WERE PRODUCT RELATED. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET.

    Description of Event or Problem · 0

    CONVERSION OF SMR ANATOMIC PROSTHESIS TO SMR REVERSE PROSTHESIS OCCURRED ON (B)(6) 2019 DUE TO DISLOCATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2010. ACCORDING TO THE INFORMATION REPORTED, WHEN THE SURGEON REMOVED THE POLY LINER THE LUGS WERE STILL INTACT BUT THERE WAS WEAR ON THE ARTICULAR SURFACE. THE HUMERAL HEAD, THE HUMERAL BODY AND THE LINER WERE EXPLANTED. PATIENT DID NOT REPORT ANY TRAUMA OR FALL. NO INFO AVAILABLE ON PATIENT ACTIVITY LEVEL. 1322.09.540 SMR HUMERAL HEAD Ø54 MM LOT #0902772 STER. 0900229 EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT # 0902772 NO ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO DISLOCATION OCCURRED ON (B)(6) 2019. ANATOMIC SMR WAS CONVERTED TO REVERSE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2010. ROOT CAUSE OF DISLOCATION IS UNKNOWN AND PATIENT DID NOT REPORT ANY TRAUMA OR FALL. ACCORDING TO THE INFORMATION REPORTED, WHEN THE SURGEON REMOVED THE POLY LINER THE LUGS WERE STILL INTACT BUT THERE WAS WEAR ON THE ARTICULAR SURFACE. THE HUMERAL HEAD, THE HUMERAL BODY AND THE LINER WERE EXPLANTED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107502 SMR HUMERAL HEAD Ø54 MM SMR HUMERAL HEAD Ø54 MM (KWT, HSD) KWT LIMACORPORATE SPA 1322.09.540 0902772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention