BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SYSTEM

    MDR report key: 20665622 · Received November 12, 2024

    Report

    Report Number
    0001822565-2024-03552
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 23, 2024
    Report Date
    March 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520554
    PMA / PMN Number
    K190660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 00877704002 LOT: 2980145 BIOLOX® OPTION, HEAD. CAT: 0106010304 LOT: 3168933 AVENIR®, STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. 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. MEDICAL RECORDS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL: IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT HEMI-HIP AND WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND MAINTAINED THE HEMI-HIP, HOWEVER UNDERWENT A SECOND REVISION ON DUE TO CONTINUED DISLOCATIONS AND WAS CONVERTED TO A TOTAL HIP. THE PATIENT THEN LOST BALANCE AND FELL REACHING FOR TOILET PAPER RESULTING IN A DISLOCATION AND WAS THEN REVISED A THIRD TIME. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THE PATIENT LOST BALANCE AND FELL REACHING FOR TOILET PAPER, HOWEVER THE PATIENT HAS A HISTORY OF DISLOCATIONS. NO PROBLEM WAS FOUND WITH THE DEVICE IN RELATION TO THE HEMATOMA AFTER REVIEW BY A HCP. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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 · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. DURING THE PROCEDURE, A LARGE HEMATOMA WAS EVACUATED AND MINIMAL NECROTIC TISSUE WAS NOTED. THE INTENTION OF THE SURGERY WAS TO ALLOW FOR CUP INGROWTH TO THE BONE AND THEN WILL RETURN TO SURGERY FOR FINAL CEMENTED STEM AND CONSTRAINED LINER. THE STEM AND HEAD WERE EXPLANTED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658790 G7 ACETABULAR SYSTEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 66760591 00889024520554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R