MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH KENEVO; EXTERNAL KNEE PROSTHETIC COMPONENT

Model Number 3C60

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 10/01/2022

Event Type  Injury  

Event Description

I have the kenevo ready to be sent back however the patient had forgotten to bring back the charger.There is an issue with returning the charger at present as the patient is in the hospital.He was due to come in last monday but missed his appointment.We had phoned but he said he would call back at a later time as he had broken his leg and was in the hospital.I phoned him again today as we had not heard from him, i thought it would be useful for you to know as he feels that something had happened to his serviced kenevo knee that resulted in his fall.This is the info i got from a very short phone call as he didn't want to talk further at present; he is currently still in hospital in the hdu and reports he had a bad break to his femur (i did not ascertain on which side).Pt reports he has undergone surgery.He is unsure how long he will be in a hospital or of the recovery and rehab involved.In terms of the accident - pt reported that the serviced keveno "gave way" and collapsed under him while crossing a road.He reported he felt there was no resistance.He reports "it nearly killed him", and that he had to drag himself to the other side of the road as no-one was around to help him and this is where he called an ambulance.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

I have the kenevo ready to be sent back however the patient had forgotten to bring back the charger.There is an issue with returning the charger at present as the patient is in the hospital.He was due to come in last monday but missed his appointment.We had phoned but he said he would call back at a later time as he had broken his leg and was in the hospital.I phoned him again today as we had not heard from him, i thought it would be useful for you to know as he feels that something had happened to his serviced kenevo knee that resulted in his fall.This is the info i got from a very short phone call as he didn't want to talk further at present; he is currently still in hospital in the hdu and reports he had a bad break to his femur (i did not ascertain on which side).Pt reports he has undergone surgery.He is unsure how long he will be in a hospital or of the recovery and rehab involved.· in terms of the accident - pt reported that the serviced keveno "gave way" and collapsed under him while crossing a road.He reported he felt there was no resistance.He reports "it nearly killed him", and that he had to drag himself to the other side of the road as no-one was around to help him and this is where he called an ambulance.Update: at 6.50 am the repaired kenevo knee failed mr b.Had a fall in the road when going to the shop.He reports the prosthesis "gave way' providing no resistance when he had put his weight on it.He managed to drag himself to the side road at the time as there were no people around at the time.This fall resulted in a hospital stay, time in the hdu and surgery to fixate the left (sound subtrochanteric neck of femur fracture.It was an angled break where a piece of bone had come away.He also reports he bled internally.He reported that at one point the doctors did not think he would pull through and his family were called to say the ir goodbyes.He did however make a good recovery and was discharged from the hospital on (b)(6) 2022.B.'s son phoned as they are wanting to start some rehab to get him up on the leg now that the femur has been fixated.He wanted to know if the loaner leg was still here so this could be swapped back as b.Has lost confidence with the serviced knee.As his son reports that his father had said that it gave way around 3 times in the week that he had it , as the unit hadn't been returne d yet his son came, and this was swapped over on the day.

• Brand Name: KENEVO
• Type of Device: EXTERNAL KNEE PROSTHETIC COMPONENT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 15758143
• MDR Text Key: 303295501
• Report Number: 9615892-2022-00016
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C60
• Device Catalogue Number: 3C60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male