BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE LINR-E-POLY NEUT-36/54 IMPLANT

    MDR report key: 4922420 · Received July 17, 2015

    Report

    Report Number
    3005985723-2015-00126
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 186636-01; FEM HEAD-CERAMIC 36MM MED-RESTORIS; LOT CODE: 004414-01; CAT. NO.: 186004-05; FEM STEM-HI OFFSET NK-SIZE 5 IMPLANT; LOT CODE: 100119-01; CAT. NO.: 186002-54; ACE SHELL-CLUST HOLE POR-54MM IMPLANT; LOT CODE: 030745-01; AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE MADE AVAILABLE. -DEVICE HISTORY REVIEW: INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED AND THE STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON PERFORMED AN I & D OF A MAKO RIGHT THA PATIENT WITH AN ORIGINAL DOS OF (B)(6) 2014. THE PATIENT HAD TESTED POSITIVE FOR A STAPH INFECTION. SURGEON REVISED THE LINER AND FEMORAL HEAD TO PERFORM THE I & D.

    Description of Event or Problem · 1

    SURGEON PERFORMED AN I & D OF A MAKO RIGHT THA PATIENT WITH AN ORIGINAL DOS OF (B)(6) 2014. THE PATIENT HAD TESTED POSITIVE FOR A STAPH INFECTION. SURGEON REVISED THE LINER AND FEMORAL HEAD TO PERFORM THE I & D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465985 ACE LINR-E-POLY NEUT-36/54 IMPLANT HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES OQG STRYKER ORTHOPAEDICS-MAHWAH 190667-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention