• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #3R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #3R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5516F302
Device Problems Failure To Adhere Or Bond (1031); Unstable (1667); Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 01/19/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Patient was revised for pain and instability. Dr. (b)(6) checked all implants for fixation. He found the femoral component was loose. Dr. (b)(6) converted the femoral component to a cemented ps knee.

 
Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as the device was not returned. Medical records received and evaluation: not performed as medical records were not provided. Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot. Conclusions: revision surgery took place due to pain and instability whereby the reported femoral component was found to be loose and subsequently exchanged to a cemented ps knee. The exact cause of the event could not be determined because insufficient information was provided. Further information such as product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. 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

Patient was revised for pain and instability. Dr. (b)(6) checked all implants for fixation. He found the femoral component was loose. Dr. (b)(6) converted the femoral component to a cemented ps knee.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON P/A PS BEADED #3R
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5438460
MDR Text Key38246466
Report Number0002249697-2016-00441
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 01/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2019
Device Catalogue Number5516F302
Device LOT NumberEJC8R
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 Received03/16/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/21/2014
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: 02/16/2016 Patient Sequence Number: 1
-
-