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

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.

• 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 Key: 14643513
• MDR Text Key: 294844749
• Report Number: 3003764610-2022-00002
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: RKN130003
• Device Catalogue Number: RKN130003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 07/08/2022
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male