MAUDE Adverse Event Report: OSSUR ICELAND RHEO KNEE 3; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT EXTERNAL

Model Number RKIN130009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/21/2016

Event Type  Injury  

Event Description

Prosthetic patient wearing rheo knee 3 prosthetic limb fell down a set of stairs and hit her head.She was planning on seeking medical attention.No further details provided.

Event Description

Prosthetic patient wearing rheo knee 3 prosthetic limb fell down a set of stairs and hit her head.Patient stated she was in a car accident the weekend before the incident and was on muscle relaxers when the incident occured and stated that may have been the contributing factor.

• Brand Name: RHEO KNEE 3
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT EXTERNAL
• 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: 5594037
• MDR Text Key: 43209862
• Report Number: 3003764610-2016-00004
• 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,Followup
• 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: RKIN130009
• Device Catalogue Number: RKN130009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR