MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 DUAL MOBILITY LINER 38MM C; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	110024461
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required an acetabular revision approximately two months post-implantation due to dissociation of the dual-mobility components, specifically the ceramic head and polyethylene liner.The patient reported an internal rotation movement of the limb while rising from an armchair.This resulted in a dislocation of the prosthesis, which was reduced in the emergency department.In reality, dissociation of the dual-mobility (dm) component was already present but went unnoticed in the ed; consequently, the patient consulted a doctor due to pain and audible noise from the prosthesis.Follow-up x-rays and ct scans revealed that the dm cup was displaced this necessitated a revision procedure for the component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: zimmer biomet part number 00877502802 bioloxa delta, ceramic femoral head, m, a¸ 28/0, taper 12/14 lot number 3252839.G2: foreign - event occurred in italy.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: G7 DUAL MOBILITY LINER 38MM C
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• 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 ; +1(574)526-0384
• MDR Report Key: 50128296
• Report Number: 0001825034-2026-02269
• Device Sequence Number: 10514289
• Product Code: LPH
• UDI-Device Identifier: 00880304703490
• UDI-Public: (01)00880304703490(17)360127(10)67706439
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 08/04/2026

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 Catalogue Number: 110024461
• Device Lot Number: 67706439
• Was Device Available for Evaluation?: Yes
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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: See H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Unknown