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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSSUR HF RHEO KNEE; PROSTHETIC KNEE

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OSSUR HF RHEO KNEE; PROSTHETIC KNEE Back to Search Results
Model Number RKN130003
Device Problem Output Problem (3005)
Patient Problems Fall (1848); Unspecified Tissue Injury (4559)
Event Date 09/18/2020
Event Type  Injury  
Event Description
Patient was standing in a ladder when the knee supposedly shut off causing the patient to fall off the ladder and breaking his hip.
 
Manufacturer Narrative
Claim by customer that knee powered off while working on ladder could not be confirmed as no device was returned for analysis.Root cause can only be suggested based on historical knowledge while no similar instance can be related to as no incident has been recorded for user operating the knee in ladder.Instances are known where user inadvertently is able to trigger wrong state in the knee, causing knee to buckle, particularly in complex activity scenario.Further to this, other factors such as trans femoral user operating in a ladder is in itself inherently dangerous activity whereas tf users are known to be prone to falling irrespective of product failure in both normal and abnormal gait scenarios.Given user history with the given knee, issues which user has been experiencing may be related to battery depletion while root cause for this cannot be confirmed but may be due to damaged power supply or housing power outlet.In any case for battery depletion, warning system is designed to maximize likelihood of user detecting issue prior to be coming hazardous.
 
Event Description
Patient was standing in a ladder when the knee supposedly shut off causing the patient to fall off the ladder and breaking his hip.
 
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Brand Name
RHEO KNEE
Type of Device
PROSTHETIC KNEE
Manufacturer (Section D)
OSSUR HF
grjothals 1-5
reykjavik, 110
IC  110
Manufacturer Contact
katla axelsdottir
grjothals 1-5
reykjavik, 110
IC   110
MDR Report Key14643513
MDR Text Key294844749
Report Number3003764610-2022-00002
Device Sequence Number1
Product Code ISW
UDI-Device Identifier05690967595418
UDI-Public05690967595418
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberRKN130003
Device Catalogue NumberRKN130003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/12/2022
Initial Date FDA Received06/09/2022
Supplement Dates Manufacturer Received05/12/2022
Supplement Dates FDA Received07/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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