MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 40E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	723-00-40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the implant sheet and op note confirm an uncomplicated primary tha was completed on (b)(6) 2023.No documentation regarding the cause of this patient's pain was provided.Should further documentation become available i would be happy to further this investigation." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient is experiencing pain.A review of the provided medical records by a clinical consultant indicated: "the implant sheet and op note confirm an uncomplicated primary tha was completed on (b)(6) 2023.No documentation regarding the cause of this patient's pain was provided.Should further documentation become available i would be happy to further this investigation." the patient also inquired if this device is part of a recall.Based on the device information it was confirmed that this device is not in scope of a recall.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.Correction: d6a.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The following devices were also listed in this report: cat# device description lot# 702-04-54e.Tridentii tritanium cluster54e.13904151a.1067-0012.Osteonics univ distal spacer 12mm.W55r91.6215-5-001.Small howmedica bone plug 1pk.Cppabd12be.6097-0735.Omnifit eon 127 no 7 35nk.De2j8r.61979010.Simplex p - us tobra fd 10-pk.Mde043.6519-1-040.Delta un.Fem hd 40mm r40 16/18.99203207.Unknown.Unknown sleeve.95022301.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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.
Event or Problem Description
As reported via medwatch mw5169246: reporter called regarding his hip replacement.In 2023, he had hip replacement done with no issues.In 2025, he began to experience pain in his hip.He states sometimes it's so painful, he is unable to stand up.He does not have a model, serial or lot number but he claims there was a recall on his device in 2024 but did not receive a recall letter in the mail.Additional info 04/16/2025: pt.Reported; i had a right hip installed on (b)(6) 2023.I'm having a lot of problems with it.The hip that they install is a trident 2 and i can't walk.I had two knees done with competitor devices.

• Brand Name: TRIDENT 0 DEG X3 INSERT 40E
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22049441
• Report Number: 0002249697-2025-00525
• Device Sequence Number: 9017816
• Product Code: LPH
• UDI-Device Identifier: 07613327297065
• UDI-Public: 07613327297065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 723-00-40E
• Device Lot Number: 2V4K47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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: 82 YR
• Patient Sex: Male