MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY; PROSTHESIS, HIP

Catalog Number	20153606
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat#: 110010246, lot#: 65095421 g7 osseoti 4 hole shell 56mm f.Cat#: 00786401420, lot#: 63186646r femoral stem press-fit collarless.Cat#: 00877503602, lot#: 3077127 bioloxâ® delta, ceramic femoral head.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 four and a half years post-implantation, the patient underwent a hip revision due to a broken liner.The patient first noticed an issue while doing leg presses in the gym.Attempts have been made and no further information has been provided.

• Brand Name: G7 LONGEVITY
• Common Device Name: PROSTHESIS, HIP
• 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 ; 5745260384
• MDR Report Key: 25497697
• Report Number: 0001822565-2026-01899
• Device Sequence Number: 21335450
• Product Code: LPH
• UDI-Device Identifier: 00889024519626
• UDI-Public: (01)00889024519626(17)250814(10)64852483
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 06/14/2026

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 Expiration Date: 08/14/2025
• Device Catalogue Number: 20153606
• Device Lot Number: 64852483
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 113 KG