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

Model Number RKNXC0005

Device Problem Defective Device (2588)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Based on information currently available no analysis possible.Knee has been returned and is in transit to the ossur quality centre for evaluation.Circumstances and injury details are under investigation.

Event Description

Knee is failing to lock when weight activated, patient fell and has broken his femur on amputated side.

Event Description

Knee is failing to lock when weight activated, patient fell and has broken his femur on amputated side.

Manufacturer Narrative

No product malfunction was identified that could have contributed to the incident.Root cause identified is knee settings do not match user profile.Incorrect parameters set by clinician.The reporter will be informed on the outcome of the analysis.

• Brand Name: RHEO KNEE XC
• Type of Device: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8252100
• MDR Text Key: 133215000
• Report Number: 3003764610-2019-00001
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690977467811
• UDI-Public: 05690977467811
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RKNXC0005
• Device Catalogue Number: RKNXC0005
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 90