MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 28MM E; PROSTHESIS, HIP

Catalog Number	010000878
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 3 years post implantation due to a disassociation.There is no further information available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d10:g3;h2;h3;h6;h10.D10: cat# unknown lot# unknown / unknown head.Cat# unknown lot# unknown / unknown cup.Product was not returned; however, pictures were provided and reviewed.Visual examination of the provided pictures identified the explanted liner.This showed evidence of the screw hole in the liner, meaning the cup was still assembled and did not disassociate from the shell.There was visible wear to the edge of the liner.No pictures of the cup or head were provided.As devices were not returned, no further analysis can be completed.Review of the device history record identified no deviations or anomalies during manufacturing.As there was insufficient information provided, a compatibility check cannot be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: small femoral head which could predispose to dislocation.A definitive root cause cannot be determined.This complaint can be confirmed via the provided x-rays.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 10 DEG E1 LINER 28MM E
• 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: 22149310
• Report Number: 0001825034-2025-01590
• Device Sequence Number: 8308763
• Product Code: PBI
• UDI-Device Identifier: 00880304526600
• UDI-Public: (01)00880304526600(17)240114(10)6463180
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: 010000878
• Device Lot Number: 6463180
• 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: 05/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK CUP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female