BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER, L1 POLY LINER FOR MB GLENOID

    MDR report key: 3833348 · Received May 9, 2014

    Report

    Report Number
    3008021110-2014-00009
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 9, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE WORK CYCLE AND RAW MATERIAL CERTIFICATE OF THE EXPLANTED POLY LINER, WITHOUT FINDING ANY ANOMALIES ON THE (B)(4) POLY LINERS WITH LOT # 201203964 RELEASED ON THE MARKET. THIS IS THE 1ST SIGNALING RECEIVED ON THIS LOT #: 31 OF THESE (B)(4) PIECES HAVE BEEN ALREADY IMPLANTED. WE ALSO RECEIVED A PHOTO OF THE EXPLANTED LINER (WHICH SHOWS THE BREAKAGE OF THE CENTRAL POLY PEG) AND A X-RAY OF THE INCIDENT. THE X-RAY SEEMS TO CONFIRM THE INTRA-OP NOTES REPORTED DURING THE REVISION, EVEN IF WE CANNOT COMPARE IT WITH THE IMMEDIATE POST-OP X-RAY OF THE ORIGINAL SURGERY (WHICH IS NOT AVAILABLE). BY THE AVAILABLE X-RAY, THE METAL BACK GLENOID HAS PROBABLY BEEN PLACED "TOO LOW" DURING THE SURGERY OF (B)(6) 2013; BECAUSE OF THIS, THE PROSTHETIC HUMERAL HEAD HAS PROBABLY APPLIED AN ECCENTRIC LOAD ON THE SUPERIOR PART OF THE LINER, CAUSING A "LEVER EFFECT" ON THE LINER. THE EXPLANTS ARE NOT AVAILABLE, THEREFORE, WE CANNOT PERFORM A DEEPER INVESTIGATION. SUMMARIZING, NO PRE-EXISTING DEFECTS WERE DETECTED ON THE POLY LINER INVOLVED. WE BELIEVE THAT THE REPORTED INSTABILITY OF THE PROSTHETIC HUMERAL HEAD (WITH POSSIBLE ROTATOR CUFF FAILURE) AND THE "TOO LOW" POSITION OF THE METAL BACK GLENOID (AND CONSEQUENTLY OF THE LINER) WITH REGARDS TO THE GLENOID BONE CONTRIBUTED TO THE LINER DISLOCATION OVER TIME, BY APPLYING AN ECCENTRIC LOAD ON THE SUPERIOR SURFACE OF THE LINER. WE ARE AWARE OF 5 TOTAL DISLOCATIONS OF L1 POLY LINERS, ON ABOUT 5300 L1 LINERS IMPLANTED WW SINCE 2003. BY THE INFORMATION RECEIVED AND BY OUR ANALYSIS, ONLY ONE OF THESE DISLOCATIONS CAN BE ATTRIBUTED MAINLY TO THE PRODUCT. ACCORDING TO THESE DATA, THE TOTAL REVISION RATE DUE TO DISLOCATION OF L1 POLY LINERS IS (B)(4), WHILE THE REVISION RATE PRODUCT-RELATED IS (B)(4). NO CORRECTIVE ACTIONS HAVE BEEN PLANNED AT THE MOMENT. (B)(4) WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 1

    ORIGINAL SURGERY ON (B)(6) 2013 WITH IMPLANT OF A SMR ANATOMIC TOTAL PROSTHESIS INCLUDING A L1 POLY LINER FOR METAL BACK GLENOID. PATIENT IS A (B)(6) YEAR OLD MAN WHO REPORTED DISCOMFORT IN HIS SHOULDER IN (B)(6) 2014. FORWARD ELEVATION PRODUCED A "CLICKING" NOISE AND "GRINDING" FEELING / SENSATION. SHOULDER STILL RELATIVELY MOBILE BUT OBVIOUSLY NOT MOVING WITH THE SAME FLUIDNESS AS BEFORE HE RETIRED TO BED. STRAIGHT FORWARD REVISION TO SMR REVERSE WITH 40MM ALL POLY GLENOSPHERE ON (B)(6) 2014. INTRA-OP NOTES DURING THE REVISION: L1 POLY LINER DISLOCATION AND BREAKAGE. HUMERAL HEAD HAD MIGRATED SUPERIORLY AND POSTERIORLY INDICATING DISLOCATION. METALLOSIS WAS APPARENT THROUGHOUT THE CAPSULE. X-RAY IN A-P SUGGEST CUFF ARTHROPATHY AS HUMERAL HEAD WAS POSITIONED SUPERIORLY AND SUB-ACROMIAL SPACE WAS REDUCED. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281373 SMR SHOULDER, L1 POLY LINER FOR MB GLENOID KWS LIMACORPORATE S.P.A. 1377.50.030 201203964

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention