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-409

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348); Joint Disorder (2373)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Doctor indicated patient complaining of knee pain and inability to extend knee, and had tka of left knee approximately 2 years ago, a knee manipulation approximately 4 months ago, and an extra articular repair for a quad injury approximately 3 months ago.Doctor decided to perform exploratory surgery on knee, found implants to be well fixed and well aligned with no wear.Doctor found knee joint surrounded by scar tissue, removed poly to access posterior part of knee.Replaced with new poly of same size.

Manufacturer Narrative

An event regarding arthrofibrosis 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: total knee arthroplasty requiring extensile exposure has resulted in arthrofibrosis with impairment of knee functionality.After failure of more conservative approaches to the problem, an extensive scar tissue release was performed in combination with liner exchange as required for adequate exposure and to restore adequate stability of the arthroplasty after the procedure.-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: review of the supplied x-ray by a clinician has concluded that total knee arthroplasty requiring extensile exposure has resulted in arthrofibrosis with impairment of knee functionality.After failure of more conservative approaches to the problem, an extensive scar tissue release was performed in combination with liner exchange as required for adequate exposure and to restore adequate stability of the arthroplasty after the procedure.The event itself and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, 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 arthrofibrosis may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Doctor indicated patient complaining of knee pain and inability to extend knee, and had tka of left knee approximately 2 years ago, a knee manipulation approximately 4 months ago, and an extra articular repair for a quad injury approximately 3 months ago.Doctor decided to perform exploratory surgery on knee, found implants to be well fixed and well aligned with no wear.Doctor found knee joint surrounded by scar tissue, removed poly to access posterior part of knee.Replaced with new poly of same size.

• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6983595
• MDR Text Key: 90428790
• Report Number: 0002249697-2017-03124
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050707
• UDI-Public: 07613327050707
• 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: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Catalogue Number: 5532-G-409
• Device Lot Number: RM2HRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 98