MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	500-11-58F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Product not returned.
Event or Problem Description
It was reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a total hip arthroplasty on (b)(6) 2016 where he was implanted with a stryker trident hip system.It is further alleged that after implantation, the patient began to experience pain and discomfort in the area of the implanted device.An orthopedic surgeon later determined that plaintiff required a revision surgery due to diagnosed loosening.The patient underwent revision surgery (b)(6) 2017.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7957797
• Report Number: 0002249697-2018-03275
• Device Sequence Number: 2338070
• Product Code: LPH
• UDI-Device Identifier: 04546540431899
• UDI-Public: 04546540431899
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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: 01/31/2021
• Device Catalogue Number: 500-11-58F
• Device Lot Number: 54296801R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention