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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F302
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
 
Event Description
It was reported by the attorney, through the filing of a legal claim, that the claimant underwent a right total knee arthroplasty on (b)(6) 2018.Its further alleged that the implant was correct, size 3, however it was cemented style when the doctor had requested a cementless style implant.After review of the x-rays, the surgeon expressed that the implant was not the correct ingrowth type surface.The patient underwent revision surgery on (b)(6) 2018 to exchange the femoral component.Update 15/april/2019: as reported by rep: it was reported a tka was planned using a press-fit femur.A cemented femur was implanted without cement.Rep was not in the operating room at the time of implantation and discovered the error when applying device labels to the billing sheet.Surgeon was notified and had to wait an additional day to revise the patient (the patient had taken a drink).The liner was removed to make room to remove the femur (there are no allegations against the liner).The cemented femoral component was revised to the planned press-fit femur.The surgeon reported that all follow-ups since the revision have been very positive and that the patient has an excellent result.
 
Manufacturer Narrative
An event regarding incorrect selection involving a cemented triathlon femoral component was reported.The event was confirmed based on the implant sheets provided.Method & results: -device evaluation and results: a review of the labels supplied on the outer carton of the device indicate: "triathlon cruciate retaining femoral right ; cemented" and "warning: this device is intended for cemented use only" -clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it is identified on the returned implant sheets that the patient underwent a tka with triathlon components including a cr femoral component (catalog 5510f302 - cemented) on (b)(6) 2018.The patient underwent revision surgery on (b)(6) 2018 whereby the femoral component was exchanged to a press-fit cr femoral component (catalog 5517-f-302).A review of the outer box labels provided with cr femoral component, catalog 5510f302, indicates "triathlon cruciate retaining femoral right ; cemented" and "warning: this device is intended for cemented use only".Based on the information provided, it can be concluded that this was a case of user error whereby a cemented implant was implanted without cement and subsequently revised.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
It was reported by the attorney, through the filing of a legal claim, that the claimant underwent a right total knee arthroplasty on (b)(6) 2018.Its further alleged that the implant was correct, size 3, however it was cemented style when the doctor had requested a cementless style implant.After review of the x-rays, the surgeon expressed that the implant was not the correct ingrowth type surface.The patient underwent revision surgery on (b)(6) 2018 to exchange the femoral component.Update 15/april/2019: as reported by rep: it was reported a tka was planned using a press-fit femur.A cemented femur was implanted without cement.Rep was not in the operating room at the time of implantation and discovered the error when applying device labels to the billing sheet.Surgeon was notified and had to wait an additional day to revise the patient (the patient had taken a drink).The liner was removed to make room to remove the femur (there are no allegations against the liner).The cemented femoral component was revised to the planned press-fit femur.The surgeon reported that all follow-ups since the revision have been very positive and that the patient has an excellent result.
 
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Brand Name
TRIATHLON CR FEM COMP #3 R-CEM
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 Key8571460
MDR Text Key143805205
Report Number0002249697-2019-01829
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/30/2023
Device Catalogue Number5510F302
Device Lot NumberEAC2H
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
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