MAUDE Adverse Event Report: OSSUR ICELAND RHEO KNEE 3; PROSHTETIC KNEE

Model Number RKN130002

Device Problems Device Operates Differently Than Expected (2913); Human Factors Issue (2948)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation under way, not complete.

Event Description

Amputee patient wearing a rheo knee 3 was walking down stairs and claimed the unit failed causing him to fall on his back.The patient had medical treatment for two weeks after falling and had a back soft tissue bruise and spinous process of the thoracic spine.

Event Description

Amputee patient wearing a rheo knee 3 was walking down stairs and claimed the unit failed causing him to fall on his back.The patient had medical treatment for two weeks after falling and had a back soft tissue bruise and spinous process of the thoracic spine.He also had radiculitis exacerbation as a result.He recovered without complications.

• Brand Name: RHEO KNEE 3
• Type of Device: PROSHTETIC KNEE
• 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 ; 9492757557
• MDR Report Key: 6304078
• MDR Text Key: 66599547
• Report Number: 3003764610-2017-00001
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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: RKN130002
• Device Catalogue Number: RKN130002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 115