MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah EXETER V40 STEM 44MM NO 0; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that there was a broken exeter stem.The patient presented in emergency with pain.X-ray taken.Showed fx of stem.

• Brand Name: EXETER V40 STEM 44MM NO 0
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Cork; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25213724
• Report Number: 0002249697-2026-00408
• Device Sequence Number: 10433841
• Product Code: JDI
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: Health Professional
• Device Expiration Date: 11/25/2023
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G7552183
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 176 LB