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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSSUR AMERICAS, INC. TOTAL KNEE 2000; PROSTHETIC KNEE JOINT COMPONENT
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OSSUR AMERICAS, INC. TOTAL KNEE 2000; PROSTHETIC KNEE JOINT COMPONENT Back to Search Results
Model Number 2000-OS
Device Problems Stretched (1601); Use of Device Problem (1670); Human Factors Issue (2948)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Above knee amputee patient wearing prosthetic hydraulic knee bent the knee to get into the car.To keep it bent, he placed his finger on the prosthetic knee.The knee then stretched out unintentionally, and because of the screw (where his finger pushed) his fingertip was pulled between the axes and torn off.The v!go technician had shown the patient how to get in the car the first time & pointed out how to avoid contact with hands or fingers in moving parts.Patient had the fingertip sewn back on.
 
Event Description
Above knee amputee patient wearing prosthetic hydraulic knee bent the knee to get into the car.To keep it bent, he placed his finger on the prosthetic knee.The knee then stretched out unintentionally, and because of the screw (where his finger pushed) his fingertip was pulled between the axes and torn off.The v!go technician had shown the patient how to get in the car the first time & pointed out how to avoid contact with hands or fingers in moving parts.Patient had the fingertip sewn back on.
 
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Brand Name
TOTAL KNEE 2000
Type of Device
PROSTHETIC KNEE JOINT COMPONENT
Manufacturer (Section D)
OSSUR AMERICAS, INC.
910 burstein drive
albion MI 49224
Manufacturer (Section G)
OSSUR AMERICAS, INC.
910 burstein drive
albion MI 49224
Manufacturer Contact
karen montes
27051 towne centre
foothill ranch, CA 92610
9492757557
MDR Report Key7049167
MDR Text Key92643368
Report Number1836248-2017-00002
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number2000-OS
Device Catalogue Number2000-OS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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