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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG KNEE JOINT; EXTERNAL ABOVE KNEE PROSTHESIS
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OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG KNEE JOINT; EXTERNAL ABOVE KNEE PROSTHESIS Back to Search Results
Model Number 3C88-1
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Bruise/Contusion (1754)
Event Date 06/12/2014
Event Type  malfunction  
Event Description
The pt fell because the knee became free (unlocked).Left hip pain occurred.
 
Manufacturer Narrative
No errors occurred during incoming inspection, all tests were passed.After evaluating the errors logged in the knee joint the valve responsible for controlling stance phase damping seemed to have positioning problems.One part of the servo unit was identified to bear some unintended coating on its surface, which could have caused the positioning problems.
 
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Brand Name
C-LEG KNEE JOINT
Type of Device
EXTERNAL ABOVE KNEE PROSTHESIS
Manufacturer (Section D)
OTTO BOCK HEALTHCARE PRODUCTS GMBH
vienna
AU 
Manufacturer Contact
reinhard wolkerstorfer
kaiserstrasse 39
wien 1070
AU   1070
3152337866
MDR Report Key4121943
MDR Text Key15103308
Report Number9615892-2014-00008
Device Sequence Number1
Product Code ISW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 07/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3C88-1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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