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

Model Number 3C98-2=S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Damage to Ligament(s) (1952)

Event Date 06/12/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned yet.Supplemental report will be submitted after receipt and evaluation of device.

Event Description

Patient golfing, transferred weight to c-leg and it buckled.

Manufacturer Narrative

The device is not returned to ottobock.It is not possible to get the device back from the customer, over 6 attempts were made and documented.Therfore it was not possible to perform the product evaluation since 12/2015 (date of the event).

• 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
• MDR Report Key: 5462619
• MDR Text Key: 39078406
• Report Number: 9615892-2016-00004
• Device Sequence Number: 1
• Product Code: ISW
• 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,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-2=S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2012
• 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): Hospitalization; Required Intervention
• Patient Weight: 120