• 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 CR BEADED #6R 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 CR BEADED #6R PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5517F602
Device Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 09/17/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding incorrect selection (user error) involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as no product was returned for evaluation. Medical records received and evaluation: not performed as no medical records were provided for review. Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusion: based on the provided information the incorrect femoral component was implanted due to human error. Revision surgery was performed on the same day to revise the ps insert component to a cs insert component which is compatible with the triathlon cr femoral component. 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

This pi is for the incorrect implantation of a primary device on (b)(6) 2018. Update provided for revision details: after implantation and closing the patient, it was discovered that a cr femur was implanted instead of the ps femur that was planned. After discussing with surgeon, patient's 5x9 ps insert was revised to a 5x9 cs insert.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON P/A CR BEADED #6R
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7967390
MDR Text Key123797351
Report Number0002249697-2018-03345
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 10/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5517F602
Device LOT NumberDR96B
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 Received09/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/18/2018
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: 10/15/2018 Patient Sequence Number: 1
-
-