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

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.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, 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 Key: 6402635
• MDR Text Key: 69894967
• Report Number: 0002249697-2017-00880
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 5530-G-411
• Device Lot Number: 04WMND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2007
• 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: 70 YR
• Patient Weight: 70