MAUDE Adverse Event Report: OSSUR ICELAND RHEO KNEE 3; ASSEMBLY, KNEE LOWER LIMB PROSTHESIS

Model Number RKN130003

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Type  Injury  

Event Description

Claim of above knee amputee patient wearing rheo knee 3 prosthetic knee while in a kitchen.The patient tripped, caught himself and fell over.When the patient impacted, he suffered a broken hip.

• Brand Name: RHEO KNEE 3
• Type of Device: ASSEMBLY, KNEE LOWER LIMB PROSTHESIS
• Manufacturer (Section D): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5659829
• MDR Text Key: 45373369
• Report Number: 3003764610-2016-00005
• Device Sequence Number: 1
• Product Code: ISW
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention