MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIDENT 10 DEG X3 INSERT 32E; Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Catalog Number	723-10-32E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: TRIDENT 10 DEG X3 INSERT 32E
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50845448
• Report Number: 0002249697-2026-00868
• Device Sequence Number: 18704108
• Product Code: JDI
• UDI-Device Identifier: 07613327339109
• UDI-Public: 07613327339109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 723-10-32E
• Device Lot Number: 7M02J5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 244 LB