MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7; PROSTHESIS, HIP

Catalog Number	010000897
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately four years post-implantation, the patient underwent a hip revision due to a head fracture suspected with radiographs following a fall from a bicycle.During surgery, the head was found fractured and the liner was found to be deteriorated from abrasion with the head fragments.Head fragments were removed and a new liner and head were placed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: cat: 650-0662 lot: 3062846 delta ceramic fem hd 36/+3mm.G2: foreign ¿ spain.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
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; b5; b7; g3; h2; h6 clinical and device codes the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately four years post-implantation, the patient underwent a hip revision due to a head fracture suspected with radiographs following a fall from a bicycle and experienced pain.During surgery, the head was found fractured and the liner was found to be deteriorated and fractured from abrasion with the head fragments.Head fragments were removed and a new liner and head were placed.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.Visual examination of the provided pictures identified the explanted device, bio-debris present.The liner show signs of wear, no fracture can be identified based on the image provided.Device not returned, further analysis cannot be made.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, initially reports they had suffered a fall with the bike, later denies it.¿radiology showed findings compatible with fracture of the right ceramic head.¿ revision: fracture of ceramic head, broken in half, free fragments; fracture of the inner polyethylene liner, posterior part intact.A definitive root cause cannot be determined.Complaint is 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.

• Brand Name: G7
• 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: 23786000
• Report Number: 0001825034-2025-03960
• Device Sequence Number: 10453034
• Product Code: PBI
• UDI-Device Identifier: 00880304526778
• UDI-Public: (01)00880304526778(17)260208(10)6962506
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/08/2026
• Device Catalogue Number: 010000897
• Device Lot Number: 6962506
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 04/08/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/10/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male