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-411

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

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.A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported: "patient had primary total knee arthroplasty implanting size 4 x 11 ps tibial bearing insert into size 4 universal baseplate, after using tibial insert impactor to fully seat insert, noticed locking wire had been partially dislodged from the insert not allowing insert to fully seat in baseplate.Doctor stated that he believed first insert was defective.Doctor asked for new insert which was available and implanted new insert without issue.".

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Conclusion: the exact cause of the event could not be determined with the provided information.Results from material analysis stated that damage observed on anterior surface of the insert at the location of the locking wire.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Since the product was returned damaged dimensional and functional could not be performed.Thus the root cause of this event could not be determined.A 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

As reported: "patient had primary total knee arthroplasty implanting size 4 x 11 ps tibial bearing insert into size 4 universal baseplate, after using tibial insert impactor to fully seat insert, noticed locking wire had been partially dislodged from the insert not allowing insert to fully seat in baseplate.Doctor stated that he believed first insert was defective.Doctor asked for new insert which was available and implanted new insert without issue.".

• 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
• MDR Report Key: 7282501
• MDR Text Key: 100582883
• Report Number: 0002249697-2018-00487
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 5532-G-411
• Device Lot Number: 637837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 83