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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5536B300
Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 02/05/2018
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no 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.

 
Event Description

The patient is a subject in the triathlon tritanium knee outcomes study. All of the following information is per the operative note. The patient had continued pain in her right (operative) knee and failed conservative measures to resolve it. X-rays revealed "aseptic loosening and catastrophic failure of the tibial component, drifting into varus. " the surgeon's postprocedural diagnosis is "right total knee arthroplasty failure. This is a failed pressfit design with aseptic loosening of the tibia with a tibial fracture from mechanical failure. " operative report notes a significant amount of varus. Revision components included cancellous screws with a cemented tibial component.

 
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Brand NameTRITANIUM BPLATE TRIATHLON S3
Type of DevicePROSTHESIS, 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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7716590
MDR Text Key114933829
Report Number0002249697-2018-02283
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 10/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device Catalogue Number5536B300
Device LOT NumberCTD3226
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 Received09/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/14/2014
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: 07/24/2018 Patient Sequence Number: 1
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