MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH GENIUM X3 (SERVICE/TEST); EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3B5-3=S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Spinal Column Injury (2081); Hip Fracture (2349); Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.According to the event description and in accordance with the results of the device investigation the user has been involved in an accident.Thus the device can be excluded to be the root cause which may have caused or contributed to the occurred event.

Event Description

Please inspect and evaluate the knee units and pylons pt was in a significant motorcycle accident and need to ensure proper functionality on components.Knee was functioning before and that this was an external force causing the damage to the units and that it was not due to malfunction of the knee patient was the driver of the motor cycle.Patient did suffer significant injuries (multiple spinal, pelvic and rib fractures as well as a broken arm) and is still in the hospital doing pt and ot patient was driver of a motorcycle and was in an accident resulting in hospital stay as well as physical therapy.This patient is a bi-lat (see also (b)(4)).

• Brand Name: GENIUM X3 (SERVICE/TEST)
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• Manufacturer (Section G): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 9971758
• MDR Text Key: 188337452
• Report Number: 9615892-2020-00004
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B5-3=S
• Device Catalogue Number: 3B5-3=S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• 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): Hospitalization; Required Intervention