BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER F.MET.BACK GLEN.STANDARD

    MDR report key: 8004665 · Received October 25, 2018

    Report

    Report Number
    3008021110-2018-00095
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    August 30, 2018
    Report Date
    May 9, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF DHR: THE CHECK OF THE MANUFACTURING CHART OF THE L1 LINER INVOLVED DID NOT SHOW ANY ANOMALY ON A TOTAL OF 32 COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT #1207107. MORE IMPORTANT, NO OTHER COMPLAINTS REPORTED ON A TOTAL OF 32 OUT OF 32 LINERS L1 ALREADY IMPLANTED WITH THE SAME LOT#. EXPLANTS ANALYSIS: NO EXPLANTS NOR PICTURES OF THE EXPLANTS AVAILABLE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: X-RAY IMAGES WERE NOT AVAILABLE FOR A CLINICAL EVALUATION. WITH THE ONLY VERY FEW INFO PROVIDED, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE EVENT REPORTED. BY THE ANALYSIS PERFORMED, THIS SEEMS TO BE A CASE NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 11 REVISIONS OF L1 LINER DUE TO WEAR ON A TOTAL OF 14537 L1 LINERS SOLD WW SINCE 2002. THIS GIVES A SPECIFIC REVISION RATE OF (B)(4). NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON THE (B)(6) 2018 DUE TO SEVERE POLY WEAR OF THE L1 LINER PREVIOUSLY IMPLANTED IN 2012 (CODE #1377.50.010, LOT #1207107, STER. #1200208) AND NECROSIS. ACCORDING TO THE INFO REPORTED, DURING CURRENT REVISION, THE GLENOID METAL BACK WAS INSTEAD LEFT IN SITU. PREVIOUS SURGERY OCCURRED ON THE (B)(6) 2012. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO METALLOSIS PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2012. ACCORDING TO THE INFO RECEIVED, PATIENT HAD NECROSIS AND POLY WEAR WAS PRESENT. NO OTHER INFO AVAILABLE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845389 LINER F.MET.BACK GLEN.STANDARD LINER F.MET.BACK GLEN.STANDARD KWS LIMACORPORATE SPA 1377.50.010 1207107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention