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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G211
Device Problems Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The sales rep at stryker (b)(4) reported that: "during a revision surgery of a right knee prosthesis on a patient initially operated on (b)(6) 2015 and who had pain and unsealing of the prosthesis but not any infection signs (no fever, no redness and normal blood test), the surgeon decided to revise her on (b)(6) 2017.During the revision surgeon, the surgeon observed wears of polyethylene on the patella and on the insert with polyethylene chips throughout the right knee + loosening of the patella the surgeon decided to postpone the implantation (in one month minimum) and made a cement spacer in order to keep the space while waiting for the next surgery.
 
Manufacturer Narrative
An event regarding patella loosening resulting in joint pain involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: mar concluded: there was explantation damage on the femoral component, tibial baseplate, tibial insert, and patella.The femoral component had scratches and biological material.The tibial baseplate was observed to have adhered bone cement.The tibial insert had burnishing, scratches, third-body indentations, and pitting.There were scratches, burnishing and third-body indentations on the patella.The damages on the tibial insert and patella are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert and patella is consistent with the absorption of synovial fluid.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: patella loosening thus was the principal problem with the bone cement debris contributing to third-body wear with the milky fluid appearance and presence of poly flakes in the joint space.This is a plausible explanation for the findings, certainly with negative cultures for infection.The cause of patellar loosening is less evident.This is usually caused by either cementation problems or malalignment of the patella in the trochlear groove of the femur.Both issues are procedure-related because part of surgical technique under responsibility of the surgeon.This can however not be further differentiated because such issues are only visible on x-rays that are not available for this case.Anyhow, failure mode must be predominantly procedure related due to the discussed potential issues although patient-related factors regarding soft tissue imbalance in the patellofemoral joint as part of the original degenerative disease may also play a role.This cannot be further differentiated due to lack of adequate clinical and radiological information.Device-related factors were excluded in the mar.Device history review: indicated that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other similar events for the reported lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.The provided records were sent to a clinician for review who confirmed that the event could "not be further differentiated because such issues are only visible on x-rays that are not available for this case." further information such as x-rays progress notes, revision operative reports, patient history & follow-up notes are needed to investigate this event further.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
The sales rep at stryker (b)(4) reported that: "during a revision surgery of a right knee prosthesis on a patient initially operated on (b)(6) 2015 and who had pain and unsealing of the prosthesis but not any infection signs (no fever, no redness and normal blood test), the surgeon decided to revise her on (b)(6) 2017.During the revision surgeon, the surgeon observed wears of polyethylene on the patella and on the insert with polyethylene chips throughout the right knee + loosening of the patella the surgeon decided to postpone the implantation (in one month minimum) and made a cement spacer in order to keep the space while waiting for the next surgery.
 
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Brand Name
X3 TRIATHLON CS INSERT #2 11MM
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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7088646
MDR Text Key93902841
Report Number0002249697-2017-03497
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/24/2019
Device Catalogue Number5531G211
Device Lot NumberLDR407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
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