MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 28A; prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Catalog Number	723-00-28A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
The following information was provided: as per pss case: the patient has a size 42mm trident 2 cluster cup with an 28mm insert, patient needs to be converted to a constrained liner for an a liner.Had a total hip replacement with a 42mm cup.The patient has instability, and the cup looks to be well fixed.Need a constrained liner to address the instability.Right side.

• Brand Name: TRIDENT 0 DEG X3 INSERT 28A
• 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: anna ryan ; raheen business park; limerick, FL NA ; EI NA ; +353()61498200
• MDR Report Key: 25302815
• Report Number: 0002249697-2026-00448
• Device Sequence Number: 9517755
• Product Code: LPH
• UDI-Device Identifier: 07613327296969
• UDI-Public: 07613327296969
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 723-00-28A
• Device Lot Number: MD5H7L
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female