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

Model Number 3B5-2

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

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

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.Due to certification issues (webtrader) this report will be submitted once access is restored.

Event Description

The patient fell with the prosthesis and broke his femur on the amputated side.The fall was not attributed to the prosthesis since the user slipped on wet grass.No error message, no malfunction, patient has fallen and has broken the stump.No fault of the prosthesis.

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 fallen due to a wet underground.Thus the device can be excluded to be the root cause which may have caused or contributed to the occurred event and as a reason for the event only a personal negligence could be determined (patient slipped on wet grass).

• Brand Name: GENIUM X3
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 8987599
• MDR Text Key: 161807983
• Report Number: 9615892-2019-00012
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: 07/09/2019
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 110