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

Model Number 3B5-2

Device Problems Unintended System Motion (1430); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Knee sticks sometimes and also moves into free swing sometimes sales rep a.M.Verified there was no fall please see attached email in tasks and later the practitioner reported a fall with injuries.There is not clear info on details of injuries just that he did have a fall which resulted in surgical repair of his contra lateral patella.He did have a fall which resulted in surgical repair of his contra lateral patella.

Manufacturer Narrative

Loss of damping resistance due to gradual loss of oil because of not meeting the mandatory routine service interval as required by the manufacturer (device should have been in for service inspection since 01-2020) - see ifu "(b)(4)": "regular maintenance (service inspections) at 12-monthly intervals is mandatory in the interest of your own safety and in order to maintain operating reliability and protect the warranty, to maintain basic safety and the essential performance characteristics, and to ensure safety in regards to emc.".

• Brand Name: GENIUM X3
• 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: 10866102
• MDR Text Key: 217084492
• Report Number: 9615892-2020-00011
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B5-2
• Device Catalogue Number: 3B5-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention