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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-G-411
Device Problems Degraded (1153); Pitted (1460); Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 02/09/2017
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Surgeon reported that he undertook a revision of a triathlon ts knee. The surgeon further reported wear of the insert posterior and base plate.

 
Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported. The event was confirmed by material analysis. Method & results: -device evaluation and results: mar concluded : abrasion damage was observed on the femoral component condyles and on the medial sides of both the uhmwpe insert and the tibial baseplate. The asymmetrical abrasion wear damage indicates that biased loading of the femoral component had occurred during use. An embedded particle on the lateral side of the insert is likely from debris resulting from contact between the femoral component and the baseplate. Yellow discoloration at multiple sites was also observed and is the result of the in vivo absorption of synovial fluid. -medical records received and evaluation: x-rays confirm wear of the poly bearing in the medial compartment with metal-metal contact and secondary varus deformity. The baseplate is loose with radiolucent lines around the entire baseplate. Posterior tibial slope of the baseplate is excessive with 12°. The femoral component also has some radiolucent lines but is not (yet) loose. There is some varus deformity across the knee arthroplasty due to significant poly wear in the medial compartment of the arthroplasty. This varus deformity should be considered secondary to the poly wear because without this, the initial alignment of the knee has probably been adequate even though no early post arthroplasty x-rays are available. Also the apparent metal-metal contact between femoral and tibial component, obvious on the x-rays and also confirmed in the materials analysis, is secondary to the same poly wear problem. -device history review: the device was manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other similar events for the lot referenced. Conclusions: the material analysis reported indicated that the asymmetrical abrasion wear damage indicates that biased loading of the femoral component had occurred during use. An embedded particle on the lateral side of the insert is likely from debris resulting from contact between the femoral component and the baseplate. This is further indicated in the medical review whereby x-rays confirm wear of the poly bearing in the medial compartment with metal-metal contact and secondary varus deformity. Principal failure mode is thus tibial baseplate malposition in excessive posterior tibial slope leading to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear and tibial baseplate loosening. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Surgeon reported that he undertook a revision of a triathlon ts knee. The surgeon further reported wear of the insert posterior and base plate.

 
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Brand NameTRIATHLON CR X3 TIBIAL INSERT
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6402635
MDR Text Key69894967
Report Number0002249697-2017-00880
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
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 05/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2012
Device Catalogue Number5530-G-411
Device LOT Number04WMND
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/11/2007
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: 03/14/2017 Patient Sequence Number: 1
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