MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 DEG X3 INSERT 36E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	723-10-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by sale rep that the patient had total hip replacement surgery on (b)(6) 2024.On the first day after surgery, the patient had hip dislocate.Therefore it is necessary to perform revision surgery on (b)(6) 2024.
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.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has surface damage consistent with implantation/explantation.Materials analysis, functional & dimensional inspection for the device were not performed as the device was returned damaged.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'conclusion/assessment: no clinical histories, pre or postoperative medical records or intraoperative or postoperative findings were provided for review.A single x-ray shows a dislocated right total hip.Film date is (b)(6) 2024.This is consistent with the pi report complaint.Event confirmation: a hip dislocation on the right can be confirmed.An x-ray shows the right hip dislocation on (b)(6) 2024.A revision surgery cannot be confirmed.Root cause: the root cause of the dislocation cannot be ascertained.A revision surgery cannot be confirmed without additional medical records." -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 by sale rep that the patient had total hip replacement surgery on (b)(6) 2024.On the first day after surgery.The patient had hip dislocate, therefore it is necessary to perform revision surgery on (b)(6) 2024.Visual inspection: visual inspection of the returned device indicated that the device has surface damage consistent with implantation/explantation.A review of the provided medical records by a clinical consultant indicated: "a hip dislocation on the right can be confirmed.An x-ray shows the right hip dislocation on (b)(6) 2024.A revision surgery cannot be confirmed.Root cause: the root cause of the dislocation cannot be ascertained.' the exact cause of the event could not be determined because insufficient information was provided.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
No new information.

• Brand Name: TRIDENT 10 DEG X3 INSERT 36E
• 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: 21082010
• Report Number: 0002249697-2025-00019
• Device Sequence Number: 8386217
• Product Code: LPH
• UDI-Device Identifier: 07613327339611
• UDI-Public: 07613327339611
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 723-10-36E
• Device Lot Number: 4X7TYJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female