MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36E; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	723-00-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscle/Tendon Damage (4532)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the patient is part of the insignia hip stem study and during a routine on site monitoring visit it was noted on the 2 year phone evaluation ((b)(6) 2025) where the patient is are asked whether they have pain, are satisfied with the surgery and if the hip is still in place, the patient reported that she was not satisfied with the surgery.There was no report of pain and the patient did not provide any comments.The clinic note from (b)(6) 2025 mentions she has chronic bilateral iliopsoas tendonitis.The patient will be followed to assess further.
Additional Manufacturer Narrative
The following devices were also listed in this report: high insignia collared hip stem; cat # 7000-6604; lot # unknown, delta v-40 ceramic head 36/-2,5; cat # 6570-0-436; lot # unknown, tridentii hemi cluster52e; cat # 702-11-52e; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36E
• 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-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25019354
• Report Number: 0002249697-2026-00348
• Device Sequence Number: 18715935
• Product Code: JDI
• UDI-Device Identifier: 07613327341959
• UDI-Public: 07613327341959
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: LT0KJV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 139 LB
• Patient Race: White