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

Model Number 3B1

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.

Event Description

Fall - the patient was taken to the hospital immediately after the fall.Patient was cycling on (b)(6) 2020, at the first break it was not possible to switch from bike mode to walking mode, neither by app nor with the device itself.So the user drove back home to connect the device to the power, after which the walking mode was usable again.The cockpit app was also deleted and reinstalled at the same time.After that, switching from bike to walking mode was possible without any problems, several attempts were made to replicate the failure.The user drove approx.1km, stopped, got off and switched to walking mode via the cockpit app, the change was confirmed by signals, the user took the first step, the joint collapsed without resistance and results in a fall.Fracture around the endoprosthetic femoral stem, the femoral stem is noticeably movable - surgery is in preparation.

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 - 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: 10356505
• MDR Text Key: 203288136
• Report Number: 9615892-2020-00006
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B1
• Device Catalogue Number: 3B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 114