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

Model Number	643-00-36F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
The clinical team provided an operative report and intra-operative record for a revision of the patient's right hip due to recurrent dislocations.Op report also states that the stem had "minimal anteversion".A stem (implanted in (b)(6) 2021), an elevated rim insert and +7.5 ceramic head (implanted in (b)(6) 2021) were revised to a restoration modular stem construct, +8 femoral head, adm/ mdm poly insert, and mdm metal liner.
Event or Problem Description
The clinical team provided an operative report and intra-operative record for a revision of the patient's right hip due to recurrent dislocations.Op report also states that the stem had "minimal anteversion".A stem (implanted in (b)(6) 2021), an elevated rim insert and +7.5 ceramic head (implanted in (b)(6) 2021) were revised to a restoration modular stem construct, +8 femoral head, adm/ mdm poly insert, and mdm metal liner.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed via medical review.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this inquiry reports two events.A primary total hip replacement performed on (b)(6) 2021 and had to be revised for recurrent dislocation on (b)(6) 2021.It also reports that another revision was necessary on (b)(6) 2021 also due to recurrent dislocation i can confirm that these events took place since i was able to review the operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Early recurrent dislocation is one of the most common reasons for revision and is multifactorial but most often relates to surgical technique." product history review: review of the device history records indicate 32 devices were manufactured and accepted into final stock on november 23, 2020 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 recurrent dislocations.This event was confirmed by clinician review of provided medical records.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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 X3 ELEVATED RIM 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12663145
• Report Number: 0002249697-2021-01725
• Device Sequence Number: 1207925
• Product Code: LPH
• UDI-Device Identifier: 07613327025101
• UDI-Public: 07613327025101
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 11/17/2025
• Device Model Number: 643-00-36F
• Device Catalogue Number: 643-00-36F
• Device Lot Number: M01PHE
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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 Sex: Male