BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY HIWALL LINER

    MDR report key: 6835778 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06806
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    March 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 06806. 0001825034 - 2017 - 06807. 0001825034 - 2017 - 06808. 0001825034 - 2017 - 06809. CONCOMITANT PRODUCTS: P/N EP-108524 E-POLY 40MM +3 HIWALL LNR SZ24 L/N 871000, P/N S001140 SELEX/MAGNUM MOD HD 40MM STD L/N 539940, P/N 103206 TAPERLOC POR FMRL 12.5X145 L/N 340620, P/N 16-116056 RNGLC+ LTD HOLE SHELL SZ56 L/N 152900, P/N 103532 TI LOW PROFILE SCREW 6.5X25MM L/N 459950, P/N 103532 TI LOW PROFILE SCREW 6.5X25MM L/N 409300, P/N 103531 TI LOW PROFILE SCREW 6.5X20MM IA6.5X20MM L/N 901580, P/N 103531 TI LOW PROFILE SCREW 6.5X20MM IA6.5X20MM L/N 409270. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THE TIME OF THIS REPORTING. IT HAS NOT BEEN REPORTED THE PATIENT WAS REVISED AND THE DEVICE(S) ARE PRESUMED YET IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06807-1, 0001825034-2017-06808-1, 0001825034-2017-06809-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP PROCEDURE AND SUBSEQUENTLY EXPERIENCED DISLOCATION AND MULTIPLE FRACTURES. PATIENT STATES IMPLANT DID NOT WORK FOR HIM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION AND FRACTURE POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614824 E-POLY HIWALL LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 871000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R