MAUDE Adverse Event Report: Zimmer Biomet, Inc. HFN LH 130 DEG 9MM X 300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	814609300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2 years and 1 month post-implantation, the intramedullary nail in the patient¿s left femur fractured, resulting in a femoral fracture, due to this, the patient underwent and additional procedure (revision surgery).No further information has been provided.
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in ecuador.H6: proposed mechanical (g04) - im nail 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.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HFN LH 130 DEG 9MM X 300MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 50103032
• Report Number: 0001825034-2026-02249
• Device Sequence Number: 15960579
• Product Code: HSB
• UDI-Device Identifier: 00887868567100
• UDI-Public: (01)00887868567100(17)271027(10)625930
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 814609300
• Device Lot Number: 625930
• 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: 07/06/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2017
• 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: 53 YR
• Patient Sex: Female