MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIDENTII TRITANIUM CLUSTER54E; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	702-04-54E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: right hip revision performed, patient had stability issues with the construct and dislocated.Surgeon removed the liner and placed three screws to better anchor the cup, then placed a constrained insert for stability.Similarly, the head was removed and replaced with a +8 mm head for stability purposes.No complaints filed against the components themselves, and no further information available at this time.Update per rep: the mdm construct dislocated from the acetabular cup and metal-liner construct, prompting dr.To revise the mdm-hip to a constrained-hip.The adm/mdm came out of the metal liner.Metal-liner did not leave the cup, femoral head did not leave the adm/mdm.

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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-Cork; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353()61498200
• MDR Report Key: 25147105
• Report Number: 0002249697-2026-00394
• Device Sequence Number: 13064681
• Product Code: JDI
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• 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,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: 702-04-54E
• Device Lot Number: 35773651
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: 75 YR
• Patient Sex: Male