MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 50MM D; PROSTHESIS, HIP

Catalog Number	110010243
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845); Aseptic loosening (4883)
Date of Event	05/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that underwent a hip revision approximately 1-month post implantation due to infection.During the procedure, the cup became loose when attempting to remove liner.The cup, liner, head, and bearing were revised.Follow-ups to gather additional information are currently in process.
Additional Manufacturer Narrative
(b)(4) d10: g7 dual mobility liner 40mm d item: 110024462 lot: 67741587.28mm dia cocr mod hd -6mm nk item: 163660 lot: 66759437.28mm i.D.40mm o.D.Size d bearing item: 110031010 lot: 67327315.G2: foreign ¿ australia.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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 50MM D
• 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: 25360382
• Report Number: 0001825034-2026-01547
• Device Sequence Number: 10653557
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)360106(10)67672555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 110010243
• Device Lot Number: 67672555
• 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: 05/10/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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 Age: 74 YR
• Patient Sex: Female