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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.
 
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.
 
Manufacturer Narrative
An event regarding malposition and fracture involving a triathlon baseplate was reported.The event was confirmed by medical review.Product evaluation and results: not performed as the device was not returned.A review of the provided medical records by a clinical consultant concluded: "the initial placement of the tibial component in slight varus, as noted on the (b)(6) 2015 post-op x-ray, resulted in a stress riser beneath the medial tibial component.In this osteoporotic patient this resulted in subsidence of the uncemented tibial component into more varus, and ultimately a proximal medial tibial fracture.Revision to a cemented stem and open reduction/internal fixation of the tibial fracture was required.In retrospect, a primary cemented total knee arthroplasty in this osteoporotic patient on steroids would have been preferable.No examination of the explanted components is available, but there is no evidence this clinical situation resulted from manufacturing or material abnormalities of the implanted tibial component." a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.The investigation concluded that the device was implanted in varus position during the primary surgery.The device subsided due to the patients bone quality which caused the medial tibial fracture.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
TRITANIUM BPLATE TRIATHLON S3
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7716590
MDR Text Key114933829
Report Number0002249697-2018-02283
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327041484
UDI-Public07613327041484
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
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
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient Weight79
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