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

Model Number	623-00-36H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2020
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 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.Device not returned.
Event or Problem Description
In providing information for a revision of the patient's left hip on (b)(6) 2022, rep provided usage sheets for (b)(6) 2020.Comparing them, a trident liner was revised to an mdm metal liner and adm/ mdm poly insert, 4 screws added to the in situ shell, and a restoration modular stem construct with a ceramic femoral head were implanted.This report is for the (b)(6) 2020 revision.
Event or Problem Description
In providing information for a revision of the patient's left hip on (b)(6) 2022, rep provided usage sheets for (b)(6) 2020 and (b)(6) 2020.Comparing them, a trident liner was revised to an mdm metal liner and adm/ mdm poly insert, 4 screws added to the in situ shell, and a restoration modular stem construct with a ceramic femoral head were implanted.This report is for the (b)(6) 2020 revision.
Additional Manufacturer Narrative
Reported event: an event regarding revision 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 was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient had multiple procedures all related to instability.Initially a primary trident liner was utilized, it was then revised to and mdm.The patient then approximately two years later required a revision where the mdm liner was replaced with a constrained insert.That constrained insert dislocated requiring another procedure.Causes of dislocation of a primary total hip are multifactorial but in most cases is surgical technique related possibly due to malposition of implants and failure to restore soft tissue tension.Later dislocation can be due to factors such as trauma and stretching out of the soft tissue envelope around the hip.Causes of dislocation of a constrained liner immediately after surgery may also be surgical technique related in that the liner may not have been properly seated.Another cause could be trauma but none was reported in this case.Regarding the event, i can confirm that a dislocation of the constrained liner occurred since i was able to see an xray showing the dislocation.I have no way to confirm any other event since i have no supporting documentation or x-rays.Regarding the root cause of the event, i believe it is likely that surgical technique played a significant role and for the late dislocation, most likely the soft tissues stretched allowing increased laxity in the joint." -product history review: review of the device history records indicate the 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 for an unknown reason.A review of the provided medical information by a clinical consultant was unable to confirm the event due to insufficient information provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary/revision operative reports 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 0° X3 INSERT 36MM ID
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14250498
• Report Number: 0002249697-2022-00631
• Device Sequence Number: 4302673
• Product Code: LPH
• UDI-Device Identifier: 07613327039559
• UDI-Public: 07613327039559
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 11/30/2024
• Device Model Number: 623-00-36H
• Device Catalogue Number: 623-00-36H
• Device Lot Number: XH1AY3
• 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: 05/27/2020
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White