BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED MODULAR HEAD STANDARD NECK 36MM

    MDR report key: 6541485 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-03056
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    January 26, 2017
    Report Date
    August 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - FREEDOM ACETABULAR LINER CATALOG#: 11-107424 LOT#: 995780, ECHO FEMORAL STEM CATALOG#: 192411 LOT#: 672690, RINGLOC ACETABULAR CUP CATALOG#: 16-104160 LOT#: 684500, LOW PROFILE SCREW CATALOG#: 103535 LOT#: 363080, LOW PROFILE SCREW CATALOG#: 103531 LOT#: 815440. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03055, 0001825034-2017-03057 & 0001825034-2017-03058.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 WAS REPORTED THAT FOLLOWING A RIGHT HIP REVISION PROCEDURE, THE PATIENT CONTINUES TO EXPERIENCE PAIN, DISCOMFORT, LIMITED RANGE OF MOTION AND TENDINITIS OF THE RIGHT HIP FLEXOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322091 FREEDOM CONSTRAINED MODULAR HEAD STANDARD NECK 36MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 876480

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other