MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI ACETABULAR SHELL; PROSTHESIS, HIP

Catalog Number	110010247
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fluid Discharge (2686)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877504002 lot# 3243024 biolox delta, ceramic femoral head.Cat# 00625006520 lot# 67283893 bone screw self-tapping.Cat# 00625006530 lot# j7916823 bone screw self-tapping.Cat# 30104007 lot# 67377895 40mm i.D.Size g neutral liner.Cat# 611201030 lot# zb2500620 z1 std col cmtless sz 3.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.
Event or Problem Description
It was reported that approximately two weeks post right hip implantation, the patient was treated with antibiotics due to erythema and fibrous exudate at the incision site.There was no confirmed infection.A course of antibiotics was given out of caution.Issue was resolved at the next follow up approximately one month later.Attempts have been made and no further information has been provided.

• Brand Name: G7 OSSEOTI ACETABULAR SHELL
• 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: 24574438
• Report Number: 0001825034-2026-00548
• Device Sequence Number: 9233553
• Product Code: LPH
• UDI-Device Identifier: 00887868355912
• UDI-Public: (01)00887868355912(17)350222(10)67130424
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110010247
• Device Lot Number: 67130424
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White