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

Catalog Number 623-10-36F

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding instability involving a trident liner was reported.The events were 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: a review of the provided medical records by a clinical consultant indicated: "this case concerns a 53-year-old male patient who underwent a primary cementless total hip arthroplasty in 2018.In 2024 the patient developed instability which was felt to be due to impingement and revision was carried out, replacing a 10° liner with a 0° eccentric liner.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty on the right since i was able to review an x-ray with the implant in place.I was able to review implant sheets from the primary procedure and also from the revision procedure but i have no other documentation such as a revision operation report or a post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty based upon the information provided.According to the summary, it was felt that we current instability was due to impingement posteriorly however no documentation is provided for this.Also, it would be unusual for improvement develop six years after surgery unless there was a change in position of the implant or polyethylene wear.If indeed the instability was due to impingement, then that would be an iatrogenic event caused by malposition of the implants, or failure to remove osteophytes, etc.Other causes of late instability could be trauma or stretching of the capsular structures, or a change in the position of the components or polyethylene wear." device history review: review of the device history records indicate 31 devices were manufactured and accepted into final stock on dec 2, 2016 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Investigation: the exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinical consultant indicated: "this case concerns a 53-year-old male patient who underwent a primary cementless total hip arthroplasty in 2018.In 2024 the patient developed instability which was felt to be due to impingement and revision was carried out, replacing a 10° liner with a 0° eccentric liner.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty on the right since i was able to review an x-ray with the implant in place.I was able to review implant sheets from the primary procedure and also from the revision procedure but i have no other documentation such as a revision operation report or a post revision x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty based upon the information provided.According to the summary, it was felt that we current instability was due to impingement posteriorly however no documentation is provided for this.Also, it would be unusual for improvement develop six years after surgery unless there was a change in position of the implant or polyethylene wear.If indeed the instability was due to impingement, then that would be an iatrogenic event caused by malposition of the implants, or failure to remove osteophytes, etc.Other causes of late instability could be trauma or stretching of the capsular structures, or a change in the position of the components or polyethylene wear." further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient revised due to instability.This is the right side.Dr.Thought the patient was impinging posteriorly so we put in a neutral liner.We wasted a liner as it still felt unstable, and we implanted the 0° eccentric liner listed on the sheet.No other information available due to hospital policy.

• Brand Name: TRIDENT 10 DEG X3 INSERT 36MM ID
• Type of Device: 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19015521
• MDR Text Key: 339082245
• Report Number: 0002249697-2024-00525
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Catalogue Number: 623-10-36F
• Device Lot Number: P32M6R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male