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
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
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 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 or Problem 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
• 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: 7282501
• Report Number: 0002249697-2018-00487
• Device Sequence Number: 19093836
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/03/2018

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: 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
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/03/2018
• 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: 69 YR
• Patient Weight: 83