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	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: device; delta v-40 ceramic head 36/-2,5; cat# 6570-0-436; lot# 19714154.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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
It was reported by the sales rep that the patient was revised due to instability.The femoral head and liner were explanted.No further information available due to hospital policy.
Event or Problem Description
It was reported by the sales rep that the patient was revised due to instability.The femoral head and liner were explanted.No further information available due to hospital policy.
Additional Manufacturer Narrative
An event regarding instability involving a trident liner 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: a review of the provided medical records by a clinical consultant indicated: "summary: this product inquiry concerns a 70-year-old male patient who underwent a cementless total hip arthroplasty on (b)(6) 2024 according to the product summary.Patient apparently developed instability of the hip and underwent revision surgery where the femoral head and liner were changed.The revision occurred on (b)(6) 2024 approximately two weeks after the primary surgery.Confirmation of event: i can confirm that the patient had a primary total hip arthroplasty since i was able to see an x-ray with a primary cementless femoral stem and primary cementless acetabular component.I was able to review and x-ray marked as a revision x-ray which showed one extra visible screw and possible better positioning of the acetabular component.I have no other confirming evidence such as office notes or operative notes.Root cause analysis: the root cause of this event cannot be determined with certainty.However, instability in the very early postoperative course can usually be attributed to surgical technique if there is no evidence of trauma which in this case there was no mention of any precipitating event.Surgical technique contributes in the position of the implant, proper version of the femoral and acetabular component, lack of impingement, and restoration of leg lengths, kinematics, and soft tissue tension in the thigh.Patient factors also come into play if the patient did not cooperate with postoperative precautionary measures.Lifestyle, activity level and bmi can also contribute.I would not assign any causality to the implant itself." -device 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 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: "summary: this product inquiry concerns a 70-year-old male patient who underwent a cementless total hip arthroplasty on (b)(6) 2024 according to the product summary.Patient apparently developed instability of the hip and underwent revision surgery where the femoral head and liner were changed.The revision occurred on (b)(6) 2024 approximately two weeks after the primary surgery." 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.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19916602
• Report Number: 0002249697-2024-01084
• Device Sequence Number: 12574000
• Product Code: LPH
• UDI-Device Identifier: 07613327339611
• UDI-Public: 07613327339611
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 723-10-36E
• Device Lot Number: 4A795W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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: 70 YR
• Patient Sex: Male