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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI POST AUGMENT SZ3 5MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI POST AUGMENT SZ3 5MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5543-A-300
Device Problems Corroded (1131); Loose or Intermittent Connection (1371); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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. 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. The femoral component disengaged from the tibial component (corrosion at the taper of the stem and tibial component). Removed the femur (cemented in with 150mm presfit triathlon stem). Distal femoral replacement connected to stryker monogram rotating hinge. Surgery completed to doctor's satisfaction.

 
Manufacturer Narrative

An event regarding loosening involving a tri post augment sz 5 5mm 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. 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. The femoral component disengaged from the tibial component (corrosion at the taper of the stem and tibial component). Removed the femur (cemented in with 150mm presfit triathlon stem). Distal femoral replacement connected to stryker monogram rotating hinge. Surgery completed to doctors satisfaction.

 
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Brand NameTRI POST AUGMENT SZ3 5MM
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5788332
MDR Text Key49373631
Report Number0002249697-2016-02263
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 03/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5543-A-300
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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