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-511

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicates the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Surgeon broke a tibial trial insert during trailing.He also had trouble seating the real tibial insert implant.He felt it was not properly seated and wasted 2 inserts in the process.He felt the medial side was tight and was causing the insert to go in at an angle.Surgeon did not feel there was anything wrong with the implants.The third insert seated properly and locked in to the tibial tray.

Manufacturer Narrative

Corrected data: device was not returned.Product available to stryker; returned to manufacturer on; reason for no evaluation.An event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Method & results: evice evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: the exact cause of the event could not be determined as insufficient information was provided.Further information such as device return is required to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded that seating/locking difficulties may arise from user-related issues associated with the preparation of the joint space prior to the attempted seating and with the technique required to correctly introduce the insert component to the baseplate.No further investigation for this event is required at this time.

Event Description

Surgeon broke a tibial trial insert during trailing.He also had trouble seating the real tibial insert implant.He felt it was not properly seated and wasted 2 inserts in the process.He felt the medial side was tight and was causing the insert to go in at an angle.Surgeon did not feel there was anything wrong with the implants.The third insert seated properly and locked in to the tibial tray.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6900794
• MDR Text Key: 87633531
• Report Number: 0002249697-2017-02870
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050783
• UDI-Public: 07613327050783
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 5532-G-511
• Device Lot Number: 70889A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 106