MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	723-00-36D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: 6570-0-536; delta v-40 ceramic head 36/+2,5; (b)(6) 0580-1-442; exeter v40 stem 44mm no 2; (b)(6) 504-02-58d-l; restoration anatomic shell size 58 left; (b)(6) 5260-5-016; osteolock bone screw 16mm; (b)(6) 5260-5-040; osteolock bone screw 40mm; (b)(6).3704-0-050; d-m 2.0mm beaded cable set ss; (b)(6).3704-0-050; d-m 2.0mm beaded cable set ss; (b)(6).3704-0-050; d-m 2.0mm beaded cable set ss; (b)(6) 3704-0-050; d-m 2.0mm beaded cable set ss; (b)(6).3704-0-050; d-m 2.0mm beaded cable set ss; (b)(6).5260-5-050; osteolock bone screw 50mm; (b)(6) 5260-5-026; osteolock bone screw 26mm; (b)(6).6704-0-520; d-m 2.0mm beaded cable set vit; (b)(6) 6704-0-520; d-m 2.0mm beaded cable set vit; (b)(6) it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Performed an i&d with head & liner exchange of a left hip due to infection.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36D
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22584148
• Report Number: 0002249697-2025-00717
• Device Sequence Number: 9340786
• Product Code: JDI
• UDI-Device Identifier: 07613327296990
• UDI-Public: 07613327296990
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 723-00-36D
• Device Lot Number: 75193R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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: 86 YR
• Patient Sex: Female