BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -3MM NECK

    MDR report key: 6772903 · Received August 7, 2017

    Report

    Report Number
    0001825034-2017-05772
    Event Type
    Injury
    Date Received
    August 7, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.THE FOLLOWING SECTIONS WERE UPDATED: DATE OF IMPLANTATION, REPORTER NAME AND ADDRESS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. E-POLY RINGLOC ACETABULAR LINER P/N EP-108222 L/N 895150; TRI-SPIKE SHELL APICAL HOLE P/N 101001 L/N 506240; MODULAR HEAD COMPONENT P/N 163668 L/N 679220; MODULAR LATERALIZED TAPERLOC FEMORAL STEM P/N 11-103200 L/N 217820. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-05770, 0001825034-2017-05771, 0001825034-2017-05772. 0001825034-2017-05773 H3 OTHER TEXT : STILL IMPLANTED

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP ARTHROPLASTY , STIFFNESS IN HANDS, NO FEELING AROUND INCISION AND LEG, PAIN AND STIFFNESS WHEN SITTING A CERTAIN WAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552685 32MM MOD HEAD COCR -3MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization