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

Catalog Number	010000996
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 30122801; lot# 66581283; 28mm i.D.Size a high wall liner.G2: foreign ¿ australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately ten months post-implantation, the patient underwent a hip revision due to a pelvic discontinuity and migration of the cup and screws.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided.Review identified the following: right total hip arthroplasty.Right pelvic fractures including fracture of proximal superior pubic ramus and fracture of proximal ischium.Fractures extend into the inferior medial and anterior acetabular wall.Acetabular cup loosening with outward rotation (migration).Generalized reduced bone mineral density.Competitor stem and head - apparent oblique fracture proximal femoral shaft confluent radiolucency at proximal medial femoral sleeve component metal-bone interface of concern for loosening.Subtle misalignment at morse taper of femoral sleeve is suggested.A definitive root cause cannot be determined regarding the acetabular fracture and loosening/migration of acetabular components.However, it was noted that the zb liner was used with a competitor head and stem.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.Per the ifu, it states not to use these products for other than labelled indications (no off-label use), " do not use the with components of any other system or manufacturer, unless authorized by zimmer biomet.¿."zimmer biomet or its affiliates are not liable for complications and/or failure that may arise from use of the device in circumstances outside of zimmer biomet¿s or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique." complaint is confirmed.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 for trends.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: G7
• 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: 23554852
• Report Number: 0001825034-2025-03612
• Device Sequence Number: 9659941
• Product Code: PBI
• UDI-Device Identifier: 00880304527447
• UDI-Public: (01)00880304527447(17)340408(10)7747747
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 010000996
• Device Lot Number: 7747747
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female