MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI PRESS-FIT STEM 14X150MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5566-S-014

Device Problems Corroded (1131); Loose or Intermittent Connection (1371); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Revision of a stryker triathlon total stabilized knee due to loosening.This is the patient's 3rd revision.The patient presented to the doctor with tibial pain.X-ray showed there had been potential loosening of the tibial component and deformity.During surgery the doctor identified tibial component with stem had become loose and removed it.The femoral component was also removed because it was not well fixed.Corrosion was noted on the taper of the stem at the junction of the stem and femoral component.Distal femoral replacement to stryker monogram rotating hinge.Surgery completed to doctors satisfaction.

Manufacturer Narrative

An event regarding loosening involving a tri press-fit stem 14 x 150mm was reported.The event was not confirmed.Method & results: -device evaluation and results: burnishing, scratching and third body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.The post of the insert fractured in fatigue.The debris and discoloration observed on the insert, femoral component and baseplate were consistent with biological material.Debris from the stabilizing post was determined to be inconclusive based on the obtained eds spectrum.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: based upon the minimal information available for review, no determination can be made regarding the cause of the three revisions of the right total knee arthroplasty.Medical review addendum: ¿based upon review of this additional documentation, no determination can be made regarding the cause of the three revision surgeries of the right total knee arthroplasty in this case.¿ -device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause of the reported event determined due to the minimal medical documentation received for the clinician to review and evaluate.The mar report concluded that, ¿burnishing, scratching and third body wear indentations were observed on the articular surface of the insert, which are common damage modes of poly inserts; the post of the insert fractured in fatigue; the debris and discoloration sites were consistent with biologic material; debris from the stabilizing post was inconclusive based on eds spectrum; and no material or manufacturing defects were observed.¿ no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Revision of a stryker triathlon total stabilized knee due to loosening.This is the patients 3rd revision.The patient presented to the doctor with tibial pain.X-ray showed there had been potential loosening of the tibial component and deformity.During surgery the doctor identified tibial component with stem had become loose and removed it.The femoral component was also removed because it was not well fixed.Corrosion was noted on the taper of the stem at the junction of the stem and femoral component.Distal femoral replacement to stryker monogram rotating hinge.Surgery completed to doctors satisfaction.

• Brand Name: TRI PRESS-FIT STEM 14X150MM
• Type of Device: PROSTHESIS, 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 Key: 5545649
• MDR Text Key: 41799699
• Report Number: 0002249697-2016-01078
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 5566-S-014
• Device Lot Number: M3N12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR