BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 20MM

    MDR report key: 22563648 · Received July 22, 2025

    Report

    Report Number
    0001825034-2025-02185
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 9, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527454
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110031010 LOT# 66528796 28MM I.D. 40MM O.D. SIZE D BEARING. CAT# 110024462 LOT # 66734077 G7 DUAL MOBILITY LINER 40MM D. CAT# 59035-16 LOT# 518943 STECKKUGELN BIOLOX DELTA HEAD L. CAT# 111-242-351 LOT# 86ADC EVOLVE STEM- CEMENTED. CAT# 111-162-002 LOT # 84E0C-23 EVOLVE DISTAL CENTRALIZER SZ WIDE. CAT# 13A2100 LOT# AC4052 CEMEX CEMENT. CAT# T860010 LOT# 8624231 NANOGEL. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. 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 (UPDATE/CORRECTED). UPDATED: D4; G3; H2; H3; H4; H6; H10. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED SCREWS, SHELL, LINER, AND HEAD. DEVICES WERE COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION COULD BE MADE FROM THE PROVIDED PICTURES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURE OF THE BONY ACETABULUM AT THE POSITION OF THE 2ND LOWER MOST SCREW IN THE ACETABULUM. THE BONE FRAGMENTS ARE SEPARATED BY APPROXIMATELY 18MM, THE BONE FRAGMENT IS DISPLACED POSTERIORLY. INCREASING HIP PAIN 7 DAYS AFTER THA. XRAY AND CT SCAN REVEALED FRACTURE OF THE ACETABULUM. IT WAS IDENTIFIED THAT ZIMMER BIOMET BEARING WAS IMPLANTED WITH A COMPETITOR DEVICE. AS PER IFU, "DUAL MOBILITY HIP BEARINGS SHOULD ONLY BE USED WITH COMPATIBLE COMPONENTS THAT ARE CURRENTLY LICENSED/CLEARED FOR MARKETING IN THE COUNTRY OF USE." IT IS UNKNOWN IF THESE OFF-LABEL USAGE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. 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 PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE WEEK POST IMPLANTATION DUE TO PAIN. RADIOGRAPHIC IMAGING DISPLAYED A BONY ACETABULAR FRACTURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784280 G7 SCREW 6.5MM X 20MM PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 7774131 00880304527454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE