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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #1 L-CEM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #1 L-CEM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5510F101
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problems Pain (1994); Swelling (2091); Injury (2348)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding baseplate loosening was reported, malposition of the triathlon femoral component was confirmed based on clinician review of the x-ray provided. Method & results: -product evaluation and results: damage was observed on the femoral component and baseplate, consistent with contact against each other. Delamination, burnishing, scratches and third-body indentations were observed on the insert condyles. These are common damage modes of uhmwpe. Debris was observed on the lateral condyle of the insert. Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate. Eds showed the femoral component, baseplate and debris from the insert were all consistent with astm f75 alloy. Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined. -clinician review: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly. Need operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components. - product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. -complaint history review: no other similar events were reported for the lot indicated. Conclusions: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly. Need operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components. The device was returned and material analysis was performed which confirmed damage was observed on the femoral component and baseplate, consistent with contact against each other. Delamination, burnishing, scratches and third-body indentations were observed on the insert condyles. These are common damage modes of uhmwpe. Debris was observed on the lateral condyle of the insert. Backside impression markings were observed on distal surface of the insert, consistent with contact against the baseplate. Eds showed the femoral component, baseplate and debris from the insert were all consistent with astm f75 alloy. Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined. The exact cause of the event could not be determined because insufficient information was provided. Additional information including operative reports, clinical reports, histopathology reports, office notes and serial x-rays are needed to fully investigate the event. 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 that patient's left knee was revised. As reported by rep: ". Progressive pain, swelling, sense of unreliability. Ct and x-rays revealed tibial loosening. Soft tissue effusion, cell count (3,500) and synovasure worrisome for possible infection. Cultures negative to date". Update: a clinician review of the provided medical records states the following; provided undated x-ray confirms subluxated femoral component posteriorly.

 
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Brand NameTRIATHLON CR FEM COMP #1 L-CEM
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8433739
MDR Text Key139236024
Report Number0002249697-2019-01368
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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
Report Date 03/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2011
Device Catalogue Number5510F101
Device LOT NumberSCXEH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/21/2006
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: 03/19/2019 Patient Sequence Number: 1
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