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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 1 RIGHT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 1 RIGHT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, Back to Search Results
Catalog Number 5540-A-102
Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
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 and pain involving a triathlon augment was reported. The event was confirmed. Method and 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 (b)(4) study. Patient was revised due to pain and femoral component loosening.

 
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Brand NameTRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 1 RIGHT
Type of DevicePROSTHESIS, 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 Key6342001
MDR Text Key67803157
Report Number0002249697-2017-00599
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
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 Received02/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2017
Device Catalogue Number5540-A-102
Device LOT NumberHZRS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/27/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/17/2017 Patient Sequence Number: 1
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