MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C98-3

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problems Fall (1848); Head Injury (1879); No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Device is currently not available for evaluation (not returned from ob usa yet); supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Patient called to advise he fell multiple times and injured his right roto-cuff and was treated for head trauma and was unable to hold balance.Hydraulics are blown, leaking fluid is everywhere.

Event Description

Patient called to advise he fell multiple times and injured his right roto-cuff and was treated for head trauma and was unable to hold balance.Hydraulics are blown, leaking fluid is everywhere.New/additional information from prosthetist regarding severity of injury (received on 2018-07-12): patient reported falls.He has a previous head injury.He did not seek medical treatment after he had falls.The injury that was reported was not related to the use of the knee.The balance issues on the checklist and the head injury was pre-existing.

Manufacturer Narrative

The investigation showed a leaky upper locking screw due to extensive contamination (hair) of device.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7633423
• MDR Text Key: 112157054
• Report Number: 9615892-2018-00017
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3
• Device Catalogue Number: 3C98-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention