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

Device Problems Mechanical Problem (1384); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 07/10/2012

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Tkr misalignment; revision surgery (b)(6) 2013 but misalignment not addressed.Misalignment creating pain.

Manufacturer Narrative

Concomitant medical products: triathlon sym patella s31x9mm, cat# 5550-l-319, lot# lcx350; tri ts baseplate size 5, cat# 5521-b-500, lot# hbxu; triathlon fix.Peg 2 per pk; cat# 5575-x-000; lot# s9mfh.Triathlon ps fem component, cemented, cat# 5515-f-502, lot# gzisa; simplex p with tobramycin 1 pack, cat# 6197-9-001, lot# mdt032.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding audible noise involving a triathlon insert was reported.The event was confirmed.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "documentation does not indicate that factors of faulty component or instrument design, manufacturing or materials are responsible for any clinical problems in this patient." device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event regarding audible noise could not be determined from the information provided.A review of the provided records by a clinical consultant concluded that the medical records "does not indicate that factors of faulty component or instrument design, manufacturing or materials are responsible for any clinical problems in this patient", no further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Tkr misalignment; revision surgery (b)(6) 2013 but misalignment not addressed.Update 2/26/16: this report is for the grinding, crunching, grating after the (b)(6) 2013 revision.Update 3/7/2016: per medical review dated (b)(6) 2016: "there is no confirmation of the alleged component malalignment.".

• Brand Name: TRIATHLON PS 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: 5365019
• MDR Text Key: 35919607
• Report Number: 0002249697-2016-00048
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 5532-G-511
• Device Lot Number: MLTMEK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2012
• 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: 65 YR
• Patient Weight: 88