MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	702-04-56F
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's right hip was revised due to dislocation of the head from the liner.A shell, poly liner, and femoral head were revised to a new shell, mdm liner, and femoral head.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident ii shell was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were provided for review.-device history review: review of the device history records indicated the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the reported lot.Conclusion: it was reported that the patient's right hip was revised due to dislocation of the head from the liner.A shell, poly liner, and femoral head were revised to a new shell, mdm liner, and femoral head.Update: shell was revised due to being implanted in a poor position per the surgeon.The event was not confirmed.The exact cause could not be determined due to limited information provided.Further information such as primary operative report and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Update: shell was revised due to being implanted in a poor position per the surgeon.

• Brand Name: TRIDENTII TRITANIUM CLUSTER56F
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23826297
• Report Number: 0002249697-2025-01472
• Device Sequence Number: 9288457
• Product Code: JDI
• UDI-Device Identifier: 07613327344004
• UDI-Public: 07613327344004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 702-04-56F
• Device Lot Number: 31404551A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male