MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36MM ID E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of primary hip surgery.Pain and dislocation.Discolored tissue intra-operative.Right side.
Event or Problem Description
Revision of primary hip surgery.Pain and dislocation.Discolored tissue intra-operative.Right side.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned devices indicated that the metal head is scratched on the outer articulating surface and the poly liner has a threaded hole consistent with a screw inserted and removed.The damage on both devices is consistent with contact with explantation tooling.The poly liner exhibits yellow discoloration in areas.-clinician review: a review of the provided medical records by a clinical consultant indicated: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical data, medical records, operative reports or labelled x-rays were provided for review.Based on the pi report a revision was performed for pain and a dislocation.Some discolored tissue was noted intraoperatively.The intraoperative photos showed some mild metal staining and what appeared to be some tissue erosion.There were corrosion products seen on the trunnion and head with some bone resorption.The x-rays, unlabeled, show some osteolysis.It is difficult to define the events without additional medical records.Event confirmation: a revision surgery can be confirmed from the pi report and intraoperative photos (unlabeled), but there were no confirmatory medical records.A dislocation cannot be confirmed.Some discoloration of tissue can be confirmed (unlabeled photo).Root cause: a root cause of the revision surgery cannot be ascertained.The tissue discoloration was likely from metallosis but again unconfirmed." -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 was revised due to pain and dislocation.Visual inspection of the returned devices indicated that the metal head is scratched on the outer articulating surface and the poly liner has a threaded hole consistent with a screw inserted and removed.The damage on both devices is consistent with contact with explantation tooling.The poly liner exhibits yellow discoloration in areas.A review of the medical records by a clinical consultant was unable to confirm the dislocation event: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical data, medical records, operative reports or labelled x-rays were provided for review.Based on the pi report a revision was performed for pain and a dislocation.Some discolored tissue was noted intraoperatively.The intraoperative photos showed some mild metal staining and what appeared to be some tissue erosion.There were corrosion products seen on the trunnion and head with some bone resorption.The x-rays, unlabeled, show some osteolysis.It is difficult to define the events without additional medical records.Event confirmation: a revision surgery can be confirmed from the pi report and intraoperative photos (unlabeled), but there were no confirmatory medical records.A dislocation cannot be confirmed.Some discoloration of tissue can be confirmed (unlabeled photo).Root cause: a root cause of the revision surgery cannot be ascertained.The tissue discoloration was likely from metallosis but again unconfirmed." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36MM ID E
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21468591
• Report Number: 0002249697-2025-00243
• Device Sequence Number: 18437202
• Product Code: LPH
• UDI-Device Identifier: 07613327039542
• UDI-Public: 07613327039542
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 623-00-36E
• Device Lot Number: WJ5HVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG