MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C98-3=9.2

Device Problem Device Handling Problem (3265)

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

Event Date 03/16/2020

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

The user was a fall and fracture.The knee was giving way.Fracture the tip of the femur - currently at rest due to severe swelling.

Manufacturer Narrative

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

Event Description

Reason for return: there was a fall and fracture.The user was a fall and fracture.The knee was giving way.The patient has not done any further treatment.( just resting at home) and she has the swelling heals and synostosis now.Is recovering smoothly.She was prescribed bandages and painkillers.And she recovered a lot.Then, it seems that rehabilitation will start from this week.Fracture the tip of the femur - currently at rest due to severe swelling; prescribed bandages and painkillers; rehabilitation.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 9883655
• MDR Text Key: 188690010
• Report Number: 9615892-2020-00003
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3=9.2
• Device Catalogue Number: 3C98-3=9.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 52