MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-509

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies. There have been no other similar events for the lot referenced. 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. Not returned.

Event Description

This pi is for revision due to loosening on (b)(6) 2015. Its reported by the attorney, through the filing of a legal claim, that the patient underwent a right revision total knee arthroplasty on (b)(6) 2015. Its further alleged that the right knee had to be revised a second time due to a loose poly insert.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8135288
• MDR Text Key: 129434750
• Report Number: 0002249697-2018-03921
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,OTHER

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/05/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/05/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/31/2020
• Device Catalogue Number: 5532-G-509
• Device LOT Number: JJ0RKT
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/08/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/05/2018 Patient Sequence Number: 1