MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 1 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

Catalog Number 5541-A-102

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The subject is enrolled in the post market (b)(4) study.Patient was revised due to pain and femoral component loosening.

Manufacturer Narrative

An event regarding loosening & pain involving a triathlon augment was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated "no dated serial x-rays and no examination of the explanted components are available.Based upon the information available for review, no determination can be made for the cause of the apparent loosening of the revision femoral component in the right total knee arthroplasty three-and-a-half years after implantation." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: based upon the medical records, patient was revised due to pain and loosening of femoral component.A review of the provided records by a clinical consultant indicated that "no dated serial x-rays and no examination of the explanted components are available.Based upon the information available for review, no determination can be made for the cause of the apparent loosening of the revision femoral component in the right total knee arthroplasty three-and-a-half years after implantation." no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

The subject is enrolled in the post market triathlon ts outcomes study.Patient was revised due to pain and femoral component loosening.

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 1 RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6341999
• MDR Text Key: 67804015
• Report Number: 0002249697-2017-00600
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 5541-A-102
• Device Lot Number: XUGF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2008
• 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: 55 YR
• Patient Weight: 84