BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 LONGEVITY NEUTRAL 36MM F

    MDR report key: 19010930 · Received April 1, 2024

    Report

    Report Number
    0001822565-2024-01011
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    November 9, 2023
    Report Date
    June 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518759
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 0101012366 LOT# 3107862 COCR HEAD, M, A¸ 36/0, TAPER 12/14. CAT# 29.00.39-100 LOT# 3102799 CLS STEM 135DEG 10.0 12/14. CAT# 110010246 LOT# 7132248 G7 OSSEOTI 4 HOLE SHELL 56MM F. G2: FOREIGN: COUNTRY: SWEDEN. CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED 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.

    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. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED ISSUE CANNOT BE CONFIRMED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A4;B4;B5;B6;G3;H2;H3;H6. CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE YEAR POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED SEVERE HIP PAIN IN THE CONTRALATERAL HIP DURING A SCHEDULED FOLLOW UP FOR A CLINICAL STUDY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED BY THE SURGEON THAT NOTHING WAS VISIBLE ON ANY OF THE X-RAYS THAT COULD EXPLAIN THE PAIN. NO INTERVENTION IS PLANNED AT THIS TIME. THE PAIN AFFECTS THE CONTRALATERAL HIP, WHICH DOES NOT HAVE IMPLANTS IN PLACE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866913 G7 LONGEVITY NEUTRAL 36MM F PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65223950 00889024518759

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other