BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR SHOULDER, L1 POLY LINER, #SMALL-R

    MDR report key: 3851183 · Received March 24, 2014

    Report

    Report Number
    3008021110-2014-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 24, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE WORK CYCLE OF THE POLY LINER AND METAL BACK INVOLVED, WITHOUT FINDING ANY DIMENSIONAL ANOMALY. A TOTAL OF (B)(4) POLY LINERS WITH THIS LOT NUMBER (201313557) HAVE BEEN RELEASED ON THE MARKET, AND WE DID NOT RECEIVE ANY OTHER SIGNALING RELATED TO THIS LOT NUMBER; BY OUR CHECKS, (B)(4) OF THESE DEVICES HAVE BEEN IMPLANTED. WE WILL NOT RECEIVE THE LINER INVOLVED IN SUCH INTRA-OPERATIVE ISSUE, AS IT REMAINED IMPLANTED. WE ALREADY PERFORMED A DETAILED ANALYSIS ON ANOTHER SIMILAR ISSUE FROM (B)(6) (MFR REPORT 3008021110-2014-00003); IN DETAIL A L1 POLY LINER AND METAL BACK BELONGING TO THE SAME LOT NUMBER OF THOSE INVOLVED IN THAT ISSUE WERE ANALYZED. AFTER A DIMENSIONAL CHECK ON THE PIECES (WHICH CONFIRMED THE ABSENCE OF DIMENSIONAL ANOMALIES), WE PERFORMED A FUNCTIONAL TEST BY COUPLING THE TWO DEVICES AS PER SURGICAL TECHNIQUE. THE LINER WAS INSERTED INTO THE METAL BACK BY PUSHING IT WITH THE FINGERS; AN AUDIBLE "CLICK" WAS HEARD DURING THE INSERTION, CONFIRMING THE FUNCTIONALITY OF THE MECHANISM. THE LINER WAS THEN STABLE INSIDE THE METAL BACK, WITHOUT ANY MICRO-MOVEMENT. WE THEN REPRODUCED THE IMPROPER ACTION PERFORMED BY THE SURGEON (IMPACTION OF THE LINER WITH AN IMPACTOR, ACTION NOT WRITTEN IN THE SMR SURGICAL TECHNIQUE); AFTER JUST 2 IMPACTIONS, THE POLY LINER STARTED HAVING MICRO-MOVEMENTS INSIDE THE METAL BACK. ACCORDING TO THE RESULTS OF THE ABOVE FUNCTIONAL TEST, TO THE ABSENCE OF PRE-EXISTING DIMENSIONAL ANOMALIES ON THE DEVICES AND TO THE FACT THAT WE DID NOT RECEIVE ANY OTHER SIGNALING RELATED TO THE LOT NUMBER INVOLVED, WE BELIEVE THAT THERE IS NO MALFUNCTION OF THE DEVICES. THE SURGEON PERFORMED AN ACTION NOT WRITTEN IN THE SURGICAL TECHNIQUE (IMPACTION TO THE LINER); OUR FUNCTIONAL TEST SHOWED THAT THIS COULD BE THE CAUSE OF THE MICRO-MOVEMENTS OF THE LINER INSIDE THE METAL BACK. WITH REGARDS TO THIS, THE SALES FORCE OF LIMA (B)(4) HAVE BEEN ALREADY INFORMED THAT THE IMPACTION OF THE L1 POLY LINERS SHOULD BE AVOIDED BECAUSE IT COULD DAMAGE THE POLY MECHANISM OF THE LINER; THE (B)(6) SURGEONS ARE NOW FULLY AWARE OF THIS. IT'S ALSO POSSIBLE THAT THE COUPLING SURFACE OF THE METAL BACK WAS NOT PERFECTLY CLEAN AND DRY BEFORE INSERTING THE LINER, CONTRIBUTING TO THE ISSUE (THE SURGICAL TECHNIQUE SPECIFIES TO CHECK CAREFULLY THAT THE COUPLING SURFACES ARE CLEAN AND DRY BEFORE INSERTING THE LINER).THIS GIVES A TOTAL OCCURRENCE RATE OF SUCH ISSUE OF (B)(4), BUT NONE OF THE ABOVE CASES SHOWED PRE-EXISTING DEFECTS ON THE DEVICES. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 1

    DURING A SURGERY DATED (B)(6) 2014, IT APPEARED THAT THE SMALL-R L1 POLY LINER HAD MICRO-MOTION FOLLOWING IMPACTION INTO THE L1 METAL BACK. ACCORDING TO THE INFO PROVIDED, THE SURGEON DID PUSH THE LINER IN WITH HIS FINGERS, NO AUDIBLE CLICK HAS BEEN HEARD SO HE IMPACTED THE LINER WITH AN IMPACTOR (ACTION NOT WRITTEN IN THE SURGICAL TECHNIQUE). ALTHOUGH THE LINER HAD MICRO-MOVEMENTS INSIDE THE METAL BACK, THE SURGEON LEFT THE DEVICE IMPLANTED AND HE WAS HAPPY WITH THE FINAL RESULT OF THE SURGERY. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173140 SMR SHOULDER, L1 POLY LINER, #SMALL-R KWS LIMACORPORATE S.P.A. 1377.50.005 201313557

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization