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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515-F-402
Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2016
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

Femoral component was undersized and in flexion. Patient was having patellar subluxation.

 
Manufacturer Narrative

An event regarding revision undersized component (use error) involving a triathlon femoral component was reported. The event was confirmed. Method and results: device evaluation and results: not performed as no device was returned. Medical records received and evaluation: the clinician review noted: "x-ray printouts available for review include an undated ap and lateral of the right knee demonstrating a cemented ts total knee arthroplasty with stable, nominal stemmed tibial component. A lateral x-ray demonstrates a translocated and flexed primary undersized femoral component with no evidence of cement fixation. Another undated ap and lateral of the right knee labeled ¿post-op¿ shows the same tibial component with a larger femoral component with modular long-stem, and now the femoral and tibial components are reduced and in nominal position. There is no evidence the revision of the undersized, malpositioned primary femoral component was the result of factors of faulty component design, manufacturing or materials. " device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. Complaint history review: there has been no other event for the lot referenced. Conclusions: the investigation concluded that an undersized femoral component was implanted. There is no evidence the revision of the undersized, malpositioned primary femoral component was the result of factors of faulty component design, manufacturing or materials. If devices and additional information become available, this investigation will be reopened.

 
Event Description

Femoral component was undersized and in flexion. Patient was having patellar subluxation.

 
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Brand NameTRIATHLON PS FEM COMPONENT, CEMENTED
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6195117
MDR Text Key63011477
Report Number0002249697-2016-03964
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,Followup
Report Date 02/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2020
Device Catalogue Number5515-F-402
Device LOT NumberMMYOA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/13/2015
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: 12/21/2016 Patient Sequence Number: 1
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