MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-409

Device Problem Mechanics Altered (2984)

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

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: triathlon p/a cr beaded #5r; cat# 5517-f-502; lot# ek4ha; tritanium bplate triathlon s4; cat# 5536-b-400; lot# ctd5065; tritanium patella-asymmetric; cat# 5552-l-320; lot# a51p.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

This patient is a subject in stryker's triathlon tritanium study.The subject had an adverse event of arthrofibrosis.The subject had limited rom postoperatively and underwent a manipulation under anesthesia on (b)(6) 2016.Following the manipulation the subject achieved 0 to 125-130 degrees of rom.The adverse event was reported as "uncertain" in terms of relationship to the device.

Manufacturer Narrative

An event regarding revision due to arthrofibrosis involving a triathlon insert component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as no medical information was provided.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded that arthrofibrosis may result from other factors not necessarily related to the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This patient is a subject in (b)(6).The subject had an adverse event of arthrofibrosis.The subject had limited rom postoperatively and underwent a manipulation under anesthesia on (b)(6) 2016.Following the manipulation the subject achieved 0 to 125-130 degrees of rom.The adverse event was reported as "uncertain" in terms of relationship to the device.

• Brand Name: TRIATHLON CR 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5784924
• MDR Text Key: 49249083
• Report Number: 0002249697-2016-02218
• 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: other,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 5530-G-409
• Device Lot Number: 8M44DE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2015
• 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): Required Intervention
• Patient Weight: 81