BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER VITAMIN-E ELEVATED LINER

    MDR report key: 5940213 · Received September 9, 2016

    Report

    Report Number
    0001822565-2016-03209
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    September 8, 2015
    Report Date
    August 4, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OQI
    PMA / PMN Number
    PK120370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: CONTINUUM TRABECULAR METAL SHELL WITH CLUSTER HOLES, CATALOG#: 00875705401, LOT#: 62762955. BONE SCREW SELF-TAPPING, CATALOG#: 00625006520, LOT#: 62757373. BONE SCREW SELF-TAPPING, CATALOG#: 00625006515, LOT#: 77002942. BIOLOX DELTA OPTION CERAMIC HEAD, CATALOG#: 650-1057, LOT#: 039210. BIOLOX OPTION TAPER ADAPTER, CATALOG#: 650-1065, LOT#: 339950. TEPERLOC POROUS LATERAL FEMORAL, CATALOG#: 11-103203, LOT#: 585060. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO INFECTION FOLLOWING A HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT UNDERWENT AN EXPLORATION OF THE LEFT TOTAL HIP REPLACEMENT WITH REVISION OF THE FEMORAL AND ACETABULAR COMPONENTS DUE TO PAIN AFTER A PRIOR REVISION. UPON ENTERING THE HIP, THE FEMORAL HEAD WAS REMOVED. THE STEM REMAINED, AS IT WAS WELL FIXED. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF LOOSENING WAS NOTED. SYNOVIAL FLUID WAS SLIGHTLY CLOUDY, YELLOWISH IN APPEARANCE AND SENT FOR GRAM STAIN. THERE WAS NO EVIDENCE OF INFECTION NOTED. THE SHELL REMAINED IMPLANTED AS WELL, HOWEVER THE SCREWS WERE REPLACED. THE LINER WAS REPLACED WITH A NEW VITAMIN E POLY LINER. A NEW CERAMIC HEAD WITH A -3.0 ADAPTER WAS IMPLANTED AS WELL. AFTER THE HIP WAS REDUCED, IT HAD EXCELLENT RANGE OF MOTION AND STABILITY. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592800 ZIMMER VITAMIN-E ELEVATED LINER HIP PROSTHESIS OQI ZIMMER, INC. 62727141

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R