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-413
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices 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 or Problem Description
As reported: "surgeon, during bilateral total knees, tried to lock the insert in to the tibial tray of the right knee, when it didn¿t lock he used a osteotome to work the insert back out and when he did he stated that the wire fell off.This happened a second time with another insert in the same knee.We did not have any other insert as we had used two.Surgeon decided to leave an insert trial in and come back on friday (b)(6) 2018 to put another insert in at that time.".
Event or Problem Description
As reported: "surgeon, during bilateral total knees, tried to lock the insert in to the tibial tray of the right knee, when it didn¿t lock he used a osteotome to work the insert back out and when he did he stated that the wire fell off.This happened a second time with another insert in the same knee.We did not have any other insert as we had used two.Surgeon decided to leave an insert trial in and come back on friday (b)(6) 2018 to put another insert in at that time.".
Additional 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 as insufficient information was provided.Further information such as 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.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.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7289664
• Report Number: 0002249697-2018-00525
• Device Sequence Number: 16617620
• Product Code: MBH
• UDI-Device Identifier: 07613327050721
• UDI-Public: 07613327050721
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 5532-G-413
• Device Lot Number: 1W82RJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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
• Patient Age: 39 YR