MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G616

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient had a right tka.The alleged implant issue was due to the anterior flange would not fit properly due to gapping, all other components fit perfectly.Rep stated the polyethlene and femoral component were waste devices, can not be used twice, had to open new devices.Surgery took longer due to surgeon repeated attempts.Surgery was completed.

Manufacturer Narrative

An event regarding revision surgery involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-medical records received and evaluation: not performed as no medical information was provided.-device history review: indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: a phase 3 investigation was performed for size/fit issue of the femoral component.The exact cause for the revision surgery of the insert is unknown.Further information such as why the insert was revised are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Patient had a right tka.The alleged implant issue was due to the anterior flange would not fit properly due to gapping, all other components fit perfectly.Rep stated the polyethylene and femoral component were waste devices, can not be used twice, had to open new devices.Surgery took longer due to surgeon repeated attempts.Surgery was completed.

• Brand Name: X3 TRIATHLON CS INSERT #6 16MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6354956
• MDR Text Key: 68505541
• Report Number: 0002249697-2017-00647
• Device Sequence Number: 1
• Product Code: MBH
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 5531G616
• Device Lot Number: LDX194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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