BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR L1 POLY LINER, # STANDARD

    MDR report key: 4956402 · Received July 31, 2015

    Report

    Report Number
    3008021110-2015-00030
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 30, 2015
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF DHRS OF THE LOT # OF LINER INVOLVED ((B)(4)) DID NOT SHOW ANY ANOMALY ON THE POLY LINER AND ON ITS RAW MATERIAL. A TOTAL OF 41 LINERS WERE MANUFACTURED WITH THE ABOVE LOT #; 32 OF THEM HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THE LOT #. EXPLANTS NOT AVAILABLE; WE RECEIVED A X-RAY WHICH SEEMS RELATED TO THE INCIDENT AND TWO PHOTOS OF THE EXPLANTS. PHOTOS OF THE EXPLANTS SHOW THAT THE CENTRAL PEG OF THE POLY LINER BROKE, THIS PROBABLY LED TO DISLOCATION OF THE POLY LINER AND DIRECT CONTACT BETWEEN HUMERAL HEAD AND METAL BACK. X-RAY SHOWS A REDUCED SPACE BETWEEN HUMERAL HEAD AND METAL BACK, CONFIRMING THE PROBABLE DISLOCATION OF THE POLY LINER AFTER ITS BREAKAGE. NO OTHER X-RAYS ARE AVAILABLE. ROOT CAUSE OF THE INCIDENT: BY THE EVENT DESCRIPTION, THE INCIDENT WAS CLEARLY DUE TO A PATIENT TRAUMA AND NO PREVIOUS PROBLEMS WERE REPORTED BY PATIENT. IN THIS REGARD, THE IFU PROVIDED WITH THE SMR SYSTEM REPORT THAT "THE FOLLOWING RISK FACTORS MAY RESULT IN POOR RESULTS WITH THIS PROSTHESIS: STRENUOUS PHYSICAL ACTIVITIES (ACTIVE SPORTS, HEAVY PHYSICAL WORK); PATIENT HISTORY OF INFECTIONS OR FALLS" AND ALSO: "EXCESSIVE PHYSI¬CAL ACTIVITY OR TRAUMA TO THE REPLACED SHOULDER JOINT CAN LEAD TO PREMATURE FAILURE OF THE SHOULDER ARTHROPLASTY THROUGH LOOSENING, FRACTURE, OR ABNORMAL WEAR OF THE PROSTHETIC IMPLANTS. THE PATIENT SHOULD BE CAUTIONED BY THE SURGEON TO GOVERN ACTIVITIES ACCORDINGLY AND ADVISED THAT THE IMPLANTS MAY FAIL". PMS DATA: 10 TOTAL CASES OF POST-OP BREAKAGE OF A L1 POLY LINER (MODEL # 1377.50.XXX) REPORTED, ON 7563 L1 LINERS SOLD WW SINCE 2003 (TOTAL BREAKAGE RATE OF L1 LINERS: 0.13%). 3 OF THESE BREAKAGES DUE TO PATIENT TRAUMA AND OTHER 3 BREAKAGES DUE TO PATIENT ROTATOR CUFF FAILURE; THIS GIVES A BREAKAGE RATE "PRODUCT-RELATED" OF 0.05% (4 EVENTS PRODUCT-RELATED). NO CORRECTIVE ACTIONS FOR THIS EVENT. LIMACORPORATE WILL KEEP THE MARKET MONITORED TO PROMPTLY DETECT POSSIBLE RECURRENCE OF SUCH EVENT. NOT RETURNED

    Description of Event or Problem · 1

    SMR ANATOMIC TOTAL IMPLANTED ON (B)(6) 2014. L1 LINER BREAKAGE OCCURRED POST-OPERATIVELY DUE TO PATIENT TRAUMA ("PATIENT WAS PLAYING FLAG FOOTBALL. PATIENT FELL AND LANDED ON HIS SHOULDER. STANDARD LINER PEG BROKE OFF IN METAL BACK CAUSING POLY TO "FLOAT"). REVISION SURGERY ON (B)(6) 2015. SURGEON REPLACED LINER, METAL BACK, HUMERAL HEAD AND ADAPTOR TAPER. THE EVENT OCCURRED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500806 SMR L1 POLY LINER, # STANDARD KWS KWS LIMACORPORATE S.P.A. 1377.50.010 201405315

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention