MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO1L125; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	0580-3-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 6942-5-055; unitrax modular endo head 55mm ; lot# aa1wy0.Cat# 6942-6-065; unitrax v40 sleeve +0mm (std); lot# 34100753.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: removal of exeter short stem and unitrax sleeve/head which was used as a spacer for infection, and repeat stage 1 revision to femoral nail spacer.Notification.
Additional Manufacturer Narrative
As this report fda ref 0002249697-2026-00388 is for second stage revision of infection, it will be cancelled and a final report will be submitted under in first stage revision of infection 0002249697-2026-00282.
Event or Problem Description
No new information.

• Brand Name: EXETER V40 STEM 50MM NO1L125
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25134400
• Report Number: 0002249697-2026-00388
• Device Sequence Number: 9453757
• Product Code: JDG
• UDI-Device Identifier: 07613327123845
• UDI-Public: 07613327123845
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: Health Professional
• Device Catalogue Number: 0580-3-501
• Device Lot Number: G8272211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male