MAUDE Adverse Event Report: Zimmer Biomet, Inc. Freedom All-Poly Hip System; prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Catalog Number	11-107122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one year and eight months post-implantation, the patient underwent a left hip revision due to unknown reasons.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat#: 802403603, lot#: 3216813, constrained head.Cat#: 300049060, lot#: 3176096, ms-30, stem.Cat#: 0100356008, lot#: 3181661, ms-30, distal centralizer.G2: foreign - event occurred in australia.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: Freedom All-Poly Hip System
• Common Device Name: prosthesis, hip, constrained, cemented or uncemented, metal/polymer
• 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 ; +1(574)526-0384
• MDR Report Key: 50913676
• Report Number: 0001825034-2026-02884
• Device Sequence Number: 5393987
• Product Code: KWZ
• UDI-Device Identifier: 00880304203587
• UDI-Public: (01)00880304203587(17)290227(10)66297210
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 11-107122
• Device Lot Number: 66297210
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Female