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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5515-F-302
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thyroid Problems (2102); Injury (2348); Reaction (2414)
Event Date 10/26/2017
Event Type  Injury  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
 
Event Description
It¿s alleged by the patient through the filing of a claim that she underwent a total knee arthroplasty on an unknown date.It is further alleged that after implantation the patient began experiencing "pain, swelling, difficulty walking, nerve damage, thyroid problems, shin conditions and high levels of cobalt and chromium".
 
Manufacturer Narrative
An event regarding rom involving a triathlon femoral component was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿on (b)(6) 2007 the patient was admitted for "left hip pain.Few months.Complains of mild discomfort right knee.With 110° of flexion.Plan: left total hip arthroplasty and manipulation under anesthesia right knee.¿ ¿on (b)(6) 2007 there is an operative report for a closed manipulation under anesthesia of the right knee and a left total hip arthroplasty for a diagnosis of "left hip arthrosis and post-operative arthrofibrosis right tka" ¿review of the extensive medical records in this case does not suggest any relationship with the various symptoms described in this patient with the total knee and hip implant components in situ.¿ -product history review: review of the product 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 of rom was confirmed but the root cause could not be determined.The event description stated, ¿it is further alleged that after implantation the patient began experiencing "pain, swelling, difficulty walking, nerve damage, thyroid problems, shin conditions and high levels of cobalt and chromium".¿ it was noted in the operative report that during the total hip surgery on 13-nov-2007 the surgeon performed closed manipulation under anesthesia for the right knee.It also noted that the pre-operative range of motion was between 0° to 85° per manipulation.After manipulation it was noted that the patient was well over 120° of flexion.The medical review concluded that, ¿review of the extensive medical records in this case does not suggest any relationship with the various symptoms described in this patient with the total knee and hip implant components in situ.¿ there is no supporting evidence that the alleged patient factors are associated with the hip and knee devices implanted.
 
Event Description
It¿s alleged by the patient through the filing of a claim that she underwent a total knee arthroplasty on an unknown date.It is further alleged that after implantation the patient began experiencing "pain, swelling, difficulty walking, nerve damage, thyroid problems, shin conditions and high levels of cobalt and chromium".
 
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Brand Name
TRIATHLON PS FEM COMPONENT, CEMENTED
Type of Device
KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7034241
MDR Text Key92096162
Report Number0002249697-2017-03360
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2011
Device Catalogue Number5515-F-302
Device Lot NumberUYBL
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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