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

Model Number 3C98-3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Skull Fracture (2077); Concussion (2192); Tooth Fracture (2428)

Event Date 04/16/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after evaluation of all device components.

Event Description

At son's house on (b)(6) 2017, patient was going down a couple steps, knee joint didn't kick out and he fell down, hit the knee and banged his elbow.The battery cap broke and wires are exposed.Knee buckled multiple times and lost stance control.Also the battery cover was broken off.Last year in (b)(6) (2016) patient fell down a few flights of stairs.He was unconscious and had a concussion.He cracked his cheek bone, back molars and eye socket and broke his jaw.His doctor has recommended eye surgery and patient was in the hospital a few weeks.

Manufacturer Narrative

The device was evaluated by the service department and the product refinement engineering department.Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the reported fall.The device operated within specification.

Event Description

At son's house on (b)(6) 2017, patient was going down a couple steps knee joint didn't kick out and he fell down, hit the knee and banged his elbow - no medical treatment required.The battery cap broke and wires are exposed.Knee buckled multiple times and lost stance control.Also the battery cover was broken off.Last year in (b)(6) (2016) patient fell down a few flights of stairs.He was unconscious and had a concussion.He cracked his cheek bone, back molars and eye socket and broke his jaw.His doctor has recommended eye surgery and patient was in the hospital a few weeks.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): 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: 6575154
• MDR Text Key: 75439451
• Report Number: 9615892-2017-00015
• 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,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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: 91