BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL R

    MDR report key: 10005214 · Received April 28, 2020

    Report

    Report Number
    3008021110-2020-00025
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    April 24, 2020
    Report Date
    September 25, 2020
    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 THE CHECK OF THE PRODUCTION DOCUMENTS OF THE SUSPECTED LOT# (CONNECTOR WITH LOT#1910757) NO PRE-EXISITING ANOMALY WAS FOUND ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT. THUS, WE CAN STATE THAT THESE COMPONENTS WERE MANUFACTURED UP TO SPECIFICATIONS. MOREOVER, ACCORDING TO OUR RECORDS AT LEAST 96 CONNECTORS (OUT OF 111 MANUFACTURED) WITH THE SAME LOT# HAVE ALREADY BEEN IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THEM. THE PRODUCTION DOCUMENTS OF THE OTHER COMPONENTS (1911840, 1916106), WERE ALSO CHECKED, WITHOUT DETECTING ANY PRE-EXISTING ANOMALY AS WELL. EXPLANT ANALYSIS: THE EXPLANTED COMPONENTS WERE RECEIVED FOR A DEEPER ANALYSIS. THE FOLLOWING ANALYSIS WERE PERFORMED: DIMENSIONAL CHECK OF THE COMPONENTS. MORPHOLOGICAL ANALYSIS OF THE CONNECTOR TAPERS, PERFORMED THROUGH THE ACQUISITION OF IMAGES WITH SCANNING ELECTRON MICROSCOPE (SEM). DIMENSIONAL CHECK: THE DIMENSIONAL ANALYSIS OF THE CONNECTOR, THE GLENOSPHERE AND THE METAL BACK GLENOID DID NOT HIGHLIGHT ANY DIMENSIONAL ANOMALIES THAT COULD HAVE LED TO THE ISSUE REPORTED, THE MEASURES WERE COMPLIANT TO DRAWING SPECIFICATIONS. MORPHOLOGICAL ANALYSIS: THE SEM ANALYSIS WAS PERFORMED ON THE CONNECTOR TAPERS, WITH THE AIM TO HIGHLIGHT POSSIBLE SIGNS/SCRATCHES ATTRIBUTABLE TO THE COUPLING OR TO THE LOOSENING OF THE CONNECTOR FROM THE METAL BACK GLENOID. BOTH THE TAPERS OF THE CONNECTOR HAVE BEEN ANALYZED: TAPER A (TO BE COUPLED WITH THE METAL BACK GLENOID, WHERE THE DISCONNECTION OCCURRED) AND TAPER B (TO BE COUPLED WITH THE GLENOSPHERE). ON THE SURFACE OF THE TAPER A, THE PLASTIC DEFORMATION OF THE MACHINING PATTERN IS NEGLIGIBLE, WHILE THERE ARE LOCALIZED DEFORMATIONS AND DEPT SCRATCHES IN MANY DIRECTIONS, NOT RELATED TO THE AXIAL DIRECTION ONLY (WHICH WOULD BE REPRESENTATIVE OF TAPER INSERTION INTO THE METAL BACK). EVIDENCES OF THE COUPLING HAS NOT BEEN OBSERVED. THESE RESULTS MAKE US BELIEVE THAT THE CONNECTOR COULD MOVE IN DIFFERENT DIRECTIONS, THE OBSERVED SIGNS COULD IN FACT BE RELATED TO A POSSIBLE MOBILIZATION BETWEEN THE CONNECTOR AND THE METAL BACK GLENOID. ON THE SURFACE OF TAPER B, THERE ARE INSTEAD WIDESPREAD SCRATCHES IN AXIAL DIRECTION AND NARROW AREAS WITH PLASTIC DEFORMATION WHICH IS SUPPOSED TO BE RELATED TO COUPLING (AND SUBSEQUENT REMOVAL) OF THE CONNECTOR FROM THE GLENOSPHERE. THE ANALYSIS ON TAPER A, MAKES US BELIEVE THAT A POSSIBLE CAUSE FOR THE DISCONNECTION BETWEEN THE CONNECTOR AND THE METAL BACK GLENOID, IS RELATED TO A SUBOPTIMAL INITIAL COUPLING BETWEEN THE TWO COMPONENTS AND/OR INSUFFICIENT ORIGINAL TIGHTENING OF THE SCREW. WE CANNOT EXCLUDE THE REPORTED FALL AS A CONTRIBUTORY CAUSE: IF THE SCREW WAS NOT CORRECTLY TIGHTENED WHEN IMPLANTED, AFTER THE FALL IT COULD HAVE BEGUN TO UNSCREW, AND A PROGRESSIVE DISCONNECTION BETWEEN THE TWO COMPONENTS COULD HAVE OCCURRED. XRAYS ANALYSIS: POST-OPERATIVE X-RAY IMAGES REFERRING TO THE ORIGINAL LIMA SMR REVERSE SURGERY AND XRAYS IMAGES TAKEN AFTER THE FALL AND COMPONENTS DISSOCIATION, WERE ANALYZED BY OUR MEDICAL EXPERT. ACCORDING TO HIS OPINION, IT IS POSSIBLE THAT THE GLENOSPHERE AND THE BASEPLATE WERE NEVER SECURELY ENGAGED. CONCLUSION: BASED ON OUR ANALYSES, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED: THE MANUFACTURING CHARTS CONFIRMED THAT THE COMPONENTS HAD BEEN MANUFACTURED UP TO SPECIFICATION, THE DIMENSIONAL ANALYSIS OF THE RETRIEVED COMPONENTS CONFIRMED THEIR FULL CONFORMITY; THE RESULTS OF MORPHOLOGICAL ANALYSIS PERFORMED ON THE CONNECTOR, SUGGEST THERE MIGHT HAVE BEEN A PHASE OF COMPONENTS MOBILIZATIONS WHILST NO SIGNS OF THE COUPLING WERE OBSERVED (ON THE TAPER THAT GOES INSERTED INTO THE METAL BACK GLENOID); OUR MEDICAL CONSULTANT, AFTER ANALYZING THE AVAILABLE XRAYS, ALSO CONFIRMED THE POSSIBILITY THAT THE CONNECTOR WAS NEVER SECURELY COUPLED WITH THE BASEPLATE. IN CONCLUSION, WE CANNOT GO BACK WITH ABSOLUTE CERTAINTY TO THE ROOT CAUSE OF THE DISCONNECTION, BUT BASED ON THE INVESTIGATION PERFORMED, THERE IS NO SUGGESTION IT WAS DUE TO THE PRODUCTS THEMSELVES. WE CAN INSTEAD SPECULATE THAT THE REPORTED ISSUE WAS MOST PROBABLY RELATED TO A SUBOPTIMAL IMPLANTATION MODALITY (INCORRECT COUPLING AND/OR INSUFFICIENT SCREW TIGHTENING) MAYBE COMBINED WITH THE FALL EXPERIENCED BY THE PATIENT. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO SIMILAR ISSUES (POST-OPERATIVE DISCONNECTION OF THE GLENOSPHERE/CONNECTOR FROM THE METAL BACK GLENOID) IS LOWER THAN 0.01%. AL THE PREVIOUS CASES WE COULD INVESTIGATE WHERE CLASSIFIED AS NOT PRODUCT-RELATED AND WERE MAINLY DUE TO SURGICAL-FACTORS AND/OR PATIENT'S TRAUMA/CONDITION. NO SPECIFIC ACTION FOR THIS CASE, LIMACORPORATE WILL KEEP THE MARKET MONITORED TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENTS.

    Description of Event or Problem · 0

    POST-OPERATIVE DISSOCIATION BETWEEN THE CONSTRUCT GLENOSPHERE (CODE 1374.09.111, LOT 1911840) + CONNECTOR (CODE 1374.15.305, LOT 1910757) AND THE METAL BACK GLENOID (CODE1375.15.650 LOT 1916106). ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT PRESENTED WITH THE DISSOCIATION EIGHT WEEKS AFTER PREVIOUS SURGERY. THE EVENTS CAN BE SUMMARIZED AS FOLLOWS: (B)(6) 2015: COMPETITOR'S STEMLESS ARTHROPLASTY; (B)(6) 2020: REVISION SURGERY TO LIMA PROSTHESIS, SMR REVERSE IMPLANTED; MID MARCH: THE PATIENT FELL. NO IMMEDIATE PAIN, BUT ON (B)(6) 2020 SHE REPORTED PAIN AND CLUNK; REVISION SURGERY OF SMR REVERSE PROSTHESIS TOOK PLACE ON (B)(6) 2020. DURING REVISION SURGERY THE PATIENT WAS FOUND TO HAVE ACTIVE INFECTION AND ALL THE COMPONENTS WERE REMOVED. THE NEXT STAGE OF THE REVISION SURGERY WILL BE RESCHEDULED ONCE THE INFECTION WILL BE ERADICATED. PATIENT DATA: FEMALE DOB: (B)(6) 1952, RHEUMATOID. EVENT OCCURRED IN UK.

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#S (1911840, 1910757, 1916106) WE WILL SUBMIT THE FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    POST-OP DISSOCIATION BETWEEN THE CONSTRUCT GLENOSPHERE (CODE 1374.09.111,LOT 1911840) + CONNECTOR (CODE 1374.15.305, LOT 1910757) AND THE METAL BACK GLENOID (CODE1375.15.650 LOT 1916106). PREVIOUS SURGERY OCCURRED 8 WEEKS PRIOR TO THE INCIDENT DATE (B)(6) 2020). THE REVISION SURGERY IS PLANNED FOR (B)(6) 2020. ACCORDING TO THE INFO RECEIVED THE PATIENT EXPERIENCED A FALL. POSSIBLE LOW GRADE INFECTION WAS ALSO REPORTED. PATIENT DATA: FEMALE DOB: (B)(6), RHEUMATOID. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470697 SMR CONNECTOR SMALL R SMR CONNECTOR SMALL R KWS LIMACORPORATE SPA 1374.15.305 1910757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention