BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT SIZE 5/13 MM RIGHT

    MDR report key: 4928283 · Received July 17, 2015

    Report

    Report Number
    3005180920-2015-00148
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    July 29, 2015
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/17/2015 WE RECEIVED THE INFORMATION ABOUT PATHOGEN, PREVIOUSLY NOT INCLUDED INTO THE CLOSURE FILE OF THE CASE: STAPH. EPIDERMIDIS. ON THE SAME DATE, WE RE-OPENED THE CASE, ADDED THE INFORMATION ABOUT THE PATHOGEN AND FINALLY CLOSED THE CASE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07/14/2015: LOT 141425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/06/2014. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE LOT HAVE ALREADY BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 06/24/2015 IT WAS VERIFIED THAT THIS IS THE FIRST EVENT ON THE LOT AND REFERENCE INVOLVED IN THE COMPLAINT. NO OTHER EVENTS ARE REGISTERED ON THE SAME STERILIZATION LOTS OF THE PIECE INVOLVED. ON 07/15/2015 (B)(4) VISUALLY INSPECTED THE RETRIEVED LINER WITH THE FOLLOWING COMMENT: THE LINER IS PERFECT IN SHAPE AND SURFACE. NOTHING TO BE UNDERLINED. ON JULY 17 THE CASE WAS CLOSED WITH THE PREPARATION OF A FINAL REPORT WITH THE INFORMATION REPORTED HERE ABOVE; DUE TO LACK OF INFORMATION IT IS IMPOSSIBLE TO ESTABLISH A CERTAIN ROOT CAUSE THAT CAUSED THE INFECTION. THERE IS NO INDICATION THE DEVICES CAUSED OR CONTRIBUTED TO THE EVENT. THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER ON THE SAME DATE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466575 GMK SPHERE TIBIAL INSERT SIZE 5/13 MM RIGHT UHMWPE KNEE PS TIBIAL INSERT JWH

    Patients

    Seq Age Sex Outcome Treatment
    1