BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD RADIAL ACETABULAR SHELL

    MDR report key: 6760934 · Received August 2, 2017

    Report

    Report Number
    0001825034-2017-05568
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    May 28, 2017
    Report Date
    February 20, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT DEVICES: EP-105933, RINGLOC HIP SYSTEM ACETABULAR LINER, (B)(4), 51-101060, MALLORY/HEAD - PF ACETABULAR COMPONENT, (B)(4), 163670, MODULAR HEAD COMPONENT, (B)(4), 103533, TITANIUM LOW PROFILE SCREWS, (B)(4), 103532, TITANIUM LOW PROFILE SCREWS, (B)(4), 31-323230, RINGLOC DRILL BIT, (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 05567, 0001825034 - 2017 - 05569, 0001825034 - 2017 - 05570, 0001825034 - 2017 - 05571, 0001825034 - 2017 - 05572.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP SURGERY. THE PATIENT DEVELOPED ELEVATED WHITE BLOOD CELL COUNT AND OTHER INFECTIOUS SYMPTOMS 3.5 WEEKS POST SURGERY. SURGEON PERFORMED IRRIGATION WITH REMOVAL OF ALL COMPONENTS AND IMPLANTED ANTIBIOTIC SPACERS. THERE WAS "GROSS PUSS" NOT JUST CLEAR FLUID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP SURGERY. THE PATIENT DEVELOPED ELEVATED WHITE BLOOD CELL COUNT AND OTHER INFECTIOUS SYMPTOMS 3.5 WEEKS POST SURGERY. SURGEON PERFORMED IRRIGATION WITH REMOVAL OF ALL COMPONENTS. THERE WAS "GROSS PUSS" NOT JUST CLEAR FLUID. PROTOLEC (SP) SPACER WAS INSERTED, AND THE PATIENT WAS REVISED AGAIN DUE TO PAIN DESPITE ANTIBIOTIC USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542204 MALLORY/HEAD RADIAL ACETABULAR SHELL HIP PROSTHESIS LZO BIOMET ORTHOPEDICS N/A 681440

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R