MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 VIT E NEUTRAL LNR 36MM G; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	30103607
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a revision approximately 3.5 months post-implantation due to dislocation and malposition of the cup.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010247, lot# 66577912 g7 osseoti 4 hole shell 58mm g.Cat# 650-0661, lot# 3252340 delta ceramic fem hd 36/0mm.G2: foreign - event occurred in new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: G7 VIT E NEUTRAL LNR 36MM G
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50495713
• Report Number: 0001822565-2026-02994
• Device Sequence Number: 10647096
• Product Code: LPH
• UDI-Device Identifier: 00889024519923
• UDI-Public: (01)00889024519923(17)300719(10)67418835
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K190660
• 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): 08/28/2026

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: 30103607
• Device Lot Number: 67418835
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2025
• 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 Narrative.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown