MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 42MM E; PROSTHESIS, HIP

Catalog Number	110024463
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: vivacit-e dm bearing 28x42mm item: 65726137 lot: 110031011 unknown head unknown stem unknown cup customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during an attempted closed reduction of the patient¿s dislocated hip, the bearing became disassociated.Subsequently, the patient underwent revision surgery and was converted to a freedom constrained liner.It was noted that the patient had prior spinal fusion surgeries.This elevates the risk for postoperative dislocations.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h4; h6.Visual inspection of the returned item # 110024463 lot # 043100 g7 dual mobility liner 42mm e performed.B, e-42mm, and lot number etch confirmed.The liner has nicks and scratches all around the i.D.There are also indentation marks around the i.D./top flat surface.There is a scratch across the top of post that stems off of the bottom/o.D.Of the liner.There is some discoloration/staining present around the o.D.Surface as well.Dimensional analysis was performed and measurements taken were conforming.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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 trends.
Event or Problem Description
It was confirmed that no further information could be provided.

• Brand Name: G7 DUAL MOBILITY LINER 42MM 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: 23463904
• Report Number: 0001825034-2025-03446
• Device Sequence Number: 9084442
• Product Code: LPH
• UDI-Device Identifier: 00880304703513
• UDI-Public: (01)00880304703513(17)320518(10)043100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 110024463
• Device Lot Number: 043100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown