MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIDENT 0 DEG X3 INSERT 36E; Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Catalog Number	723-00-36E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported; i had a hip replacement in (b)(6) 2023 with a stryker trident 2 hip component.Recently the hip is malfunctioning; the hip has stopped pivoting and it's not moving or turning i'm not sure what's going on with it.It's like i'm out from a force it.I have a doctor's appointment with the orthopedic next wednesday.What i noticed when i pulled the serial number up of the number of the instrument, it had a recall on it.In pain and currently on crutches.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36E
• Common Device Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50564009
• Report Number: 0002249697-2026-00795
• Device Sequence Number: 18630859
• Product Code: LPH
• UDI-Device Identifier: 07613327341959
• UDI-Public: 07613327341959
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 723-00-36E
• Device Lot Number: E11530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 210 LB