BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMD 20-1060 GLENOID PSI

    MDR report key: 11259257 · Received February 1, 2021

    Report

    Report Number
    3008021110-2020-00123
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    August 18, 2020
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DHRS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE LOT# 2011065. GLENOID IMPACTOR INVOLVED IN THE ISSUE WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION (THE IMPACTOR WAS DISPOSED OF AT THE HOSPITAL). THE GLENOID IMPACTOR PSI WAS USED DURING A SURGERY WHERE A LIMA COMPASSIONATE USE DEVICE WAS IMPLANTED - PLEASE REFER TO THE POST-OPERATIVE FOLLOW UP REPORT FOR FDA COMPASSIONATE USE REQUEST (B)(4) - DR. (B)(6) SUBMITTED BY (B)(6) SR REGULATORY AND QUALITY MANAGER ON (B)(6) 2021 TO EXPANDED ACCESS IDE&HDE PROGRAMS (B)(4) FOR FURTHER DETAILS. BASED ON THE FEEDBACK PROVIDED BY THE COMPLAINT SOURCE AND ACCORDING TO OUR TECHNICAL ANALYSIS, IT IS POSSIBLE THAT THE ANTERIOR FLANGE OF THE PSI GLENOID IMPACTOR WAS TOO THICK, AND THE SURGEON INVOLVED EXPERIENCED SOME DIFFICULTIES IN INSERTING IT IN THE CUSTOMIZED IMPLANT EVENTUALLY BROKING THE GLENOID IMPACTOR. THE GLENOID COMPONENT WAS NOT DAMAGED. ALL THIS HAPPENED TO THE TABLE NEXT TO THE PATIENT, SO THE PSI NEVER WENT IN CONTACT WITH THE PATIENT. SURGERY WAS SUCCESSFULLY CONCLUDED BY USING STANDARD INSTRUMENTS. THE INVOLVED BROKEN PSI WAS ORIGINALLY DESIGNED TO BE USED WITH A TRIAL SAFETY SCREW TO SECURE THE POSITION. THE THREADED PORTION IS FOR THE INSERTION OF THE IMPACTOR. CORRECTIVE/PREVENTIVE ACTIONS: FOLLOWING SURGEON'S FEEDBACK, IT WAS DECIDED TO CHANGE THE DESIGN FOR THIS KIND OF IMPACTOR (WHICH IS RARELY USED), PROVIDING IT WITH A BIGGER CAVITY AND STRICTER CONTROL OF THE FLANGE THICKNESS FOLLOWING THE SLS MANUFACTURING. TO THE BEST OF OUR KNOWLEDGE, THERE ARE NO OTHER CASES WHICH REQUIRED THIS KIND OF PSI. PLEASE CONSIDER THIS REPORT (REQUIRED BY FDA) AS AN INITIAL-FINAL COMBINED ONE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE EXPERIENCED ON (B)(6) 2020 WITH THE GLENOID IMPACTOR PATIENT-SPECIFIC INSTRUMENT OR PSI (PRODUCT CODE 9096.66.J07.6, LOT# 2011065) DURING A SHOULDER SURGERY WHERE A COMPASSIONATE USE DEVICE (PATIENT-MATCHED GLENOID COMPONENT) WAS IMPLANTED. BOTH THE PSI AND PATIENT-MATCHED GLENOID COMPONENT WERE APPROVED FOR USE UNDER FDA COMPASSIONATE USE REQUEST # (B)(4). ACCORDING TO THE INFORMATION REPORTED, THE GLENOID IMPACTOR DID NOT FIT ONTO THE GLENOID COMPONENT DURING INTRAOPERATIVE TRAILING AND BROKE. IT MUST BE SPECIFIED THAT GLENOID IMPACTOR DID NOT COME INTO CONTACT WITH THE PATIENT. PSI'S PURPOSE WAS TO DISPERSE THE IMPACTION FORCES DURING IMPLANTATION, BUT, SINCE IT WAS NOT NECESSARY FOR THE SURGERY, THE SURGERY WAS EVENTUALLY COMPLETED BY USING A LIMA'S 510(K) CLEARED INSTRUMENTS AND IT WAS REPORTED A 15 MINS DELAY DUE TO THIS ISSUE. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158393 CMD 20-1060 GLENOID PSI GLENOID IMPACTOR PSI LXH LIMACORPORATE S.P.A. 9096.66.J07 2011065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other