MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; PROSTHESIS, HIP

Catalog Number	010000999
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately six months post implantation due to a pelvic fracture that was experienced after a fall.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 110010270 / g7 osseoti multihole 64mm h / lot #: 65829711.G2: australia.Multiple mdr¿s were filed for this event: 0001825034-2024-02426.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.It was reported the patient fell in a nursing home, however the reason for the fall is unknown.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.

• Brand Name: G7 SCREW 6.5MM X 30MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21123892
• Report Number: 0001825034-2025-00102
• Device Sequence Number: 15373461
• Product Code: PBI
• UDI-Device Identifier: 00880304527478
• UDI-Public: (01)00880304527478(17)330224(10)7428523
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 010000999
• Device Lot Number: 7428523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female