• 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 #4L 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 #4L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5517-F-401
Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408); Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problems Failure of Implant (1924); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 01/25/2017
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The customer reported that they revised an uncemented triathlon knee after 3 months. Infection was suspected given the early failure, as there is radiolucent lines on the femoral side. However, the surgeon has so far ruled out infection as the cause of failure, given all blood testing, aspirate and cultures are negative & is alleging that the revision is due to implant deficiencies.

 
Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: a triathlon femoral were returned for visual inspection which concluded fibrous tissue is evident on the triathlon femoral. Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: revision of triathlon cementless knee devices some 7-weeks post arthroplasty due to osteolysis of the implant-bone interface in a male patient of (b)(6) years (b)(6) with near normal body weight (bmi = 28). Infection was suspected prior to revision and biopsies taken at 2-weeks post primary surgery but all cultures were negative while infection markers also proved negative. X-rays confirm osteolysis of the entire femoral implant-bone interface while the tibial interface is not very well visible. Femoral component is slightly undersized. Explant photographs of device during revision do not reveal obvious pathology. No bone ingrowth is seen while minor spots of fibrous tissue are present along the border of the femoral component. The current information is not adequate to fully explain this case although some suspicion for infection remains theoretically present and a procedure-related factor relating to suboptimal preparation of the distal femur can be suspected, as based upon the reported ¿toggling¿ but has no additional evidence to prove with certainty. More radiological and clinical information might help resolve this aspect. 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 reported lot. Conclusions: based on the medical review which indicated, the current information is not adequate to fully explain this case although some suspicion for infection remains theoretically present and a procedure-related factor relating to suboptimal preparation of the distal femur can be suspected, as based upon the reported ¿toggling¿ but has no additional evidence to prove with certainty. More radiological and clinical information might help resolve this aspect. The exact cause of the event could not be determined due to insufficient information received. However further information such as x-rays & clinical information are needed to complete the investigation for determining 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

The customer reported that they revised an uncemented triathlon knee after 3 months. Infection was suspected given the early failure, as there is radiolucent lines on the femoral side. However, the surgeon has so far ruled out infection as the cause of failure, given all blood testing, aspirate and cultures are negative & is alleging that the revision is due to implant deficiencies.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON P/A CR BEADED #4L
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6354544
MDR Text Key68180072
Report Number0002249697-2017-00641
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK051380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5517-F-401
Device Catalogue Number5517F401
Device LOT NumberAB72P1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/14/2016
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: 02/23/2017 Patient Sequence Number: 1
-
-