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

Model Number 3C98-1

Device Problems Failure To Service (1563); Improper or Incorrect Procedure or Method (2017)

Patient Problem Fracture, Arm (2351)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

There is massive air in the hydraulics because of the patient not meeting any service interval recommended by the manufacturer (required every two years - device should have been in for service in (b)(6) 2013 and (b)(6) 2015).Air in the hydraulic establish slowly which leads to a loss of performance and could be relevant for the fall.

Event Description

The device is swinging freely, the patient has fallen a couple of times.Patient went to urgent care (ambulant), ulnar avulsion fracture, currently in cast.

• Brand Name: C-LEG KNEE JOINT
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer (Section G): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110 ; 1 5233786
• MDR Report Key: 5878118
• MDR Text Key: 52162839
• Report Number: 9615892-2016-00010
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2016

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: 3C98-1
• Device Catalogue Number: 3C98-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 79