MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 44MM F; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	110024464
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a g7 dual mobility hip revision due to dislocation.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
(b)(4).D10: 28mm i.D.44mm o.D.Size f bearing item: 110031012 lot: 65254637 delta cer fem hd 28/-3mm t1 item: 650-1159 lot: 3090670 tprlc 133 fp type1 pps so 6.0 item: 51-100060 lot: 51-100060 g7 osseoti 4 hole shell 54mm f item: 110010245 lot: 65300582 bone screw self-tapping 6.5 mm dia.20 mm length item: 00625006520 lot: 65292772 the product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6 visual examination of the provided picture identified the explanted devices, bio-debris present, however this cannot be used to confirm the reported event.Device not returned further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.

• Brand Name: G7 DUAL MOBILITY LINER 44MM F
• 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 ; 5745260384
• MDR Report Key: 25315821
• Report Number: 0001825034-2026-01479
• Device Sequence Number: 15984698
• Product Code: LPH
• UDI-Device Identifier: 00880304703520
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Catalogue Number: 110024464
• Device Lot Number: 739070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown