MAUDE Adverse Event Report: Zimmer Biomet, Inc. FIB ANATOMIC LOCK LEFT 4H STE; Orthopaedic fixation plate, non-bioabsorbable

Catalog Number	856206004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent fibular fixation with an anatomical plate approximately 1 month ago and subsequently developed postoperative erythema around the implant with delayed recovery.The patient underwent an additional surgery approximately 2 days ago where the wound was incised and pus was discharged.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.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: FIB ANATOMIC LOCK LEFT 4H STE
• Common Device Name: Orthopaedic fixation plate, non-bioabsorbable
• 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: 50082232
• Report Number: 0001825034-2026-02215
• Device Sequence Number: 10753241
• Product Code: HRS
• UDI-Device Identifier: 00887868061950
• UDI-Public: (01)00887868061950(17)350623(10)67330064
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 856206004
• Device Lot Number: 67330064
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Unknown