BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 42MM E

    MDR report key: 19962890 · Received August 12, 2024

    Report

    Report Number
    0001825034-2024-01998
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    August 1, 2024
    Report Date
    May 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703513
    PMA / PMN Number
    K150522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: COUNTRY: AUSTRALIA. D10: CAT# EP-200148 LOT# 483760 ACT ARTIC E1 HIP BRG 28X42MM. CAT# 110010244 LOT# 7210423 G7 OSSEOTI 3 HOLE SHELL 52MM E. CAT# 010000999 LOT# 6478740 G7 SCREW 6.5MM X 30MM. CAT# 010000999 LOT# 7055643 G7 SCREW 6.5MM X 30MM. CAT# 00811400200 LOT# 65179060 FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM. CAT# 00801102020 LOT# 64590495 ALLEN MEDULLARY CEMENT PLUGS 1-20 MM DIAMETER FLANGE/10 MM DIAMETER. CAT# 802202802 LOT# 3068754 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH. CUSTOMER HAS INDICATED THAT THE PRODUCT 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. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3 THE FOLLOWING SECTION WAS CORRECTED: EXPLANT DATE: D6B (IT WAS DETERMINED THAT THE ITEM WAS NOT EXPLANTED DURING THE REVISION SURGERY.) 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: B4;G3;H2;H3;H6;H10 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ECCENTRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP CONSISTENT WITH THE REPORTED BEARING DISASSOCIATION AND DISPLACEMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WAS CONFIRMED BASED ON THE X-RAY FINDINGS. 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 2 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DISLOCATED HIP WAS DUE TO A GLUTE INJURY, WHICH WAS INITIALLY REPAIRED DURING THE PRIMARY PROCEDURE. AN ATTEMPT WAS MADE AT A CLOSED REDUCTION OF THE HIP; HOWEVER, DURING THE CLOSED REDUCTION, THE BEARING SEPARATED FROM THE HEAD AND LODGED IN GLUTE SOFT TISSUE. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301651 G7 DUAL MOBILITY LINER 42MM E PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 536020 00880304703513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H