• 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 PRIM CEM FXD BPLT #5 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 PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520B500
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problems Pain (1994); Injury (2348)
Event Date 01/24/2017
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
Original knee tibial component was put in slight varus. Patient was complaining about pain. This was the patients left knee.
 
Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported. The event was confirmed through x rays provided. -device evaluation and results: not performed as the product was not returned. -medical records received and evaluation: revision of triathlon baseplate due to varus malposition some 5-months post arthroplasty in a (b)(6) year old male patient with near normal body weight (bmi
=
(b)(6)). The baseplate was exchanged for a universal baseplate with stem extender and 13-mm cs bearing. This patient had reportedly pain in the knee ever since time of implantation and this can certainly be attributed to the ligament unbalance in the knee causing overload with pain due to ligament and synovial tissue overstretch. This may cause gait problems as well. A significant malposition of knee components was thus present, especially the tibial baseplate in varus which was confirmed by physical examination prior to revision surgery as well as evident on the available x-rays. Because optimal component position is related to surgical technique under responsibility of the surgeon, principal failure mode is procedure-related without apparent patient-related or device-related matters present consistent with the type of failure. -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: medical review concluded that component malposition with varus deformity of the baseplate causing pain contributed to revision surgery with baseplate and insert exchange. 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
Original knee tibial component was put in slight varus. Patient was complaining about pain. This was the patients left knee.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON PRIM CEM FXD BPLT #5
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
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6350552
MDR Text Key68065796
Report Number0002249697-2017-00628
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
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 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number5520B500
Device Lot NumberAMN8C
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 Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2015
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: 02/22/2017 Patient Sequence Number: 1
-
-