BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEU +5MM E1 LINER 40MM F

    MDR report key: 12802629 · Received November 12, 2021

    Report

    Report Number
    0001825034-2021-03107
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    October 7, 2021
    Report Date
    January 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304673564
    PMA / PMN Number
    K142882
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT WAS REVISED FOR RECURRENT DISLOCATIONS. LINER AND HEAD WERE EXCHANGED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO (RELATED) DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF 00-7850-013-00, LOT 63992895, STEM TAPER. REF 00-7859-012-00, LOT 64017753, DISTAL CENTRALIZER. REF 110010245, LOT 64866560, SHELL. REF 00-8777-040-02, LOT 2981748, HEAD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL LEFT PARTIAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO PAIN. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 6 MONTHS LATER FOR RECURRENT DISLOCATIONS. DURING THE REVISION, IT WAS NOTED THE IMPLANTS WERE IN PROPER ORIENTATION, EXTREMELY HARD TO DISLOCATE, AND HAD A 15° FLEXION CONTRACTURE. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703360 G7 NEU +5MM E1 LINER 40MM F PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 6293398 00880304673564

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H