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

Model Number 3C98-3

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 10/21/2022

Event Type  Injury  

Event Description

Incorrect behavior during level walking - hydraulic unit failed, and is making noise pt was in office turned to exit office, smooth leveled floor, unit failed and pt fell to floor, resulting in breaking his hip.Pt has been using this alignment since it's been installed as of 10/2018.Pt is trilateral, veteran, he fell opposing side.(contralateral side) pt fell to ground, due to unit failure, fell on his opposing side hip and broke hip.Had to have surgery.

Manufacturer Narrative

Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Incorrect behavior during level walking - hydraulic unit failed, and is making noise pt was in office turned to exit office, smooth leveled floor, unit failed and pt fell to floor, resulting in breaking his hip.Pt has been using this alignment since it's been installed as of (b)(6) 2018.Pt is trilateral, veteran, he fell opposing side.(contralateral side) pt fell to ground, due to unit failure, fell on his opposing side hip and broke hip.Had to have surgery.Unit locks up in early toe of tripping the patient.Stubbing the toe is the easiest way to describe it.Patient is a right trans humoral.Right transfemoral.Left transtibial.The units inability to now accommodate the patient's ambulatory needs is the cause of the falls.The unit # (b)(6).Had been in use from new.The unit was ambulated in my office and were i not close to the patient and able to catch him another episode would have been experienced.The unit locks up intermittently.Unexpectedly.Without cause or warning.This patients gait and ability to ambulate safely and unassisted has not decreased or been altered from his first prosthesis to date.The unit failed to operate properly.

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.

• Brand Name: C-LEG
• Type of Device: MECHATRONIC EXTERNAL 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
• MDR Report Key: 15867760
• MDR Text Key: 304329777
• Report Number: 9615892-2022-00018
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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; Hospitalization
• Patient Sex: Male