MAUDE Adverse Event Report: OSSUR H/F RHEO KNEE 3 WP; PROSTHETIC KNEE

Model Number RKN13140

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/24/2017

Event Type  Injury  

Event Description

Above knee amputee patient wearing a rheo knee 3 prosthetic knee fell on left side and hit his head on a door.As a result of the fall, the patient suffered a broken shoulder, injured back, neck and left side of hip.Left shoulder and hip surgery performed on (b)(6) 2017.Patient scheduled for back surgery on (b)(6) 2018.Patient claims that during the fall the prosthesis twisted and the socket came loose.Patient is receiving pain injections.

Event Description

While walking through a door opening, an above knee amputee patient wearing a rheo knee 3 prosthetic knee fell on left side and hit his head on a door.As a result of the fall, the patient suffered a broken shoulder, injured back, neck and left side of hip.Patient claims that during the fall the prosthesis twisted and the socket came loose.

Manufacturer Narrative

Device evaluation: incoming inspection summary: · step count: 204.868 · rheologic software settings: no abnormal settings were detected · warnings: 21 battery low, this warning is logged when the battery goes below some level.This is no danger to the user.· high end torque (het) is marginally below target limits.Het tests resistance while a load is applied to the actuator, is a constant state of the actuator and does not happen unexpectedly.This can also be managed with manual settings.The test results indicate around 3,5% reduction in maximum high end torque and therefore does not indicate a noticeable loss of performance during level ground walking from a user perspective.In addition, het failed due to fluid leakage and this leakage is probably caused by the impact of the fall.Therefore, it is excluded that het is cause of the incident.· cover broken loose · knee passed all other quality checks.Failure probability: · covers breaking loose due to impact has a resolution through (b)(4).In 2016 the occurrence of loose or broken covers was 160 and none of those resulted in an incident.Root cause: provided information indicates external factors leading to the fall, which subsequently damaged the product.Factors such as surface which is being walked on, for instance doorstep while walking in doorway, or having an obstacle may be contributing.It was reported that patient is taking medication for blood pressure control.Low blood pressure may also have contributed in terms of reduced awareness and related factors which can affect the pattern of gait and therefore lead to involuntarily triggering wrong actions by the knee.No product malfunction has been identified which could have lead to the fall.Final comments from the manufacturer: no product malfunction has been identified that could have contributed to the incident.Failure is found likely to be due to user activity and other circumstances as described above.Trans femoral amputees are known to fall more frequently, regardless of product malfunction but with low occurrence of injuries.Based on these findings, no further action is required.

• Brand Name: RHEO KNEE 3 WP
• Type of Device: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR H/F; grjothals 5; reykjavik, 110 ; IC 110
• MDR Report Key: 7113365
• MDR Text Key: 94727066
• Report Number: 3003764610-2017-00005
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• PMA/PMN Number: E165555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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: RKN13140
• Device Catalogue Number: RKN13140
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 82