MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: i have been using bilateral hip prostheses for 8 years.On (b)(6) 2026, i began to feel spontaneous pain in my hip (right side), and the pain progressed with loss of strength and mobility in the limb.I was then taken by ambulance to the hospital on (b)(6) 2026, where an x-ray revealed that the prosthesis was broken.This occurred spontaneously, without any associated trauma.Since then, my life has changed repeatedly, as from that day on i could no longer walk, work, or perform simple daily activities.I started needing help with even small necessities like dressing, going to the bathroom, lying down, etc.In addition to the significant emotional impact on me and my family, i was physically and financially affected by having to bear the costs of medical expenses and medications, and by the health damage related to the surgery, as i have sickle cell anemia, which required greater care and involved risks.I did experience complications after the prosthesis replacement surgery, developing a pulmonary thromboembolism, which further weakened my health, requiring oxygen and prolonging my hospital stay.I also needed four blood transfusions.All of this, unfortunately, was a consequence of the exeter prosthesis material breaking down so suddenly and prematurely, and it continues to affect my life to this day, as recovery from the surgery has been slow and difficult.

• Brand Name: EXETER V40 STEM 30MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25315216
• Report Number: 0002249697-2026-00479
• Device Sequence Number: 20150401
• Product Code: JDI
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 0580-1-300
• Device Lot Number: 1057924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2026
• Initial 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: Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 58 KG