MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH GENIUM X3 - BIONIC PROSTHETIC SYSTEM; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3B5-X3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081); Hip Fracture (2349)

Event Date 03/10/2018

Event Type  Injury  

Manufacturer Narrative

Device is currently not available for evaluation (not returned from ob usa yet); supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Fall occurred on (b)(6) 2018, evening.Contralateral side caught a lip on a step and he lost balance.It happened in a hockey arena, in the stands, his good foot caught on a lip, and he lost balance and fell down the stairs.The fall was severe with multiple injuries.The fall was not due to a malfunction of the prosthesis.The patient broke t10 and several ribs and shattered the acetabulum of his left hip.

Manufacturer Narrative

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

• Brand Name: GENIUM X3 - BIONIC PROSTHETIC SYSTEM
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 7398587
• MDR Text Key: 104405652
• Report Number: 9615892-2018-00012
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B5-X3
• Device Catalogue Number: 3B5-X3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 82