MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO1L125; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	0580-3-371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); High metal ion levels (4847)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: a healthcare professional reported a patient who underwent bilateral total hip arthroplasty at another hospital using the company¿s implants.Postoperatively, the patient has been experiencing various nonspecific symptoms.The patient and family raised a concern regarding a potential metal allergy based on information obtained from the internet.The reporting healthcare professional considers the likelihood of metal allergy to be very low from a clinical perspective.No definitive diagnosis of metal allergy has been made, and no causal relationship between the reported symptoms and the implants has been established.

• Brand Name: EXETER V40 STEM 37.5MM 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25670741
• Report Number: 0002249697-2026-00558
• Device Sequence Number: 17568180
• Product Code: JDG
• UDI-Device Identifier: 07613327123739
• UDI-Public: 07613327123739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/30/2026

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: Health Professional
• Device Catalogue Number: 0580-3-371
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/30/2026
• 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: Other
• Patient Sex: Unknown