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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Surgeon broke a tibial 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.
Additional Manufacturer Narrative
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.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.No medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.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.Not available.
Event or Problem Description
Surgeon broke a tibial 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
• 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: 6900199
• Report Number: 0002249697-2017-02867
• Device Sequence Number: 538359
• Product Code: MBH
• UDI-Device Identifier: 07613327050783
• UDI-Public: 07613327050783
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: 5532-G-511
• Device Lot Number: 8R4MLK
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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: 64 YR
• Patient Weight: 106