MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah EXETER V40 STEM 44MM NO 4; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	0580-1-444
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Periprosthetic fracture (4902)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: stryker tha revised due to periprosthetic fracture, original stem head and liner removed, replaced with exeter long stem (44 no 3 260), mdm liner (e) and 28 +4 head.

• Brand Name: EXETER V40 STEM 44MM NO 4
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50057667
• Report Number: 0002249697-2026-00652
• Device Sequence Number: 16116521
• Product Code: JDI
• UDI-Device Identifier: 04546540153333
• UDI-Public: 04546540153333
• 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: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 0580-1-444
• Device Lot Number: unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown