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

Model Number	RKNXC0005
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Knee is failing to lock when weight activated, patient fell and has broken his femur on amputated side.
Event or Problem Description
Knee is failing to lock when weight activated, patient fell and has broken his femur on amputated side.
Additional 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
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8252100
• Report Number: 3003764610-2019-00001
• Device Sequence Number: 2462961
• Product Code: ISW
• UDI-Device Identifier: 05690977467811
• UDI-Public: 05690977467811
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: RKNXC0005
• Device Catalogue Number: RKNXC0005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Weight: 90