MAUDE Adverse Event Report: OTTOBOCK SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCARE OTTOBOCK X3 KNEE UNIT; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Model Number I DO NOT HAVE THE KNEE ANYMORE

Device Problems Loose or Intermittent Connection (1371); Physical Resistance/Sticking (4012)

Patient Problems Fall (1848); Pain (1994)

Event Date 12/14/2018

Event Type  Injury  

Event Description

I am an above the knee amputee.I have the ottobock x3 knee unit with anti stumble technology.I went out to feed my fish and my prosthetic foot caught a rock and i stumbled.I fell straight down on my femur and it drove into the ground.I hit so hard it snapped a ½ inch titanium rod in the knee unit.My prosthetic leg was rendered unusable.I had to crawl.25 miles back to my house.I was in excruciating pain and went around on crutches for 4 days while my prosthetic guy got a replacement.Ottobock shipped over an inferior product and sent my knee to (b)(4) for further testing.They were all concerned about what happened to me because they knew their product did not work as it was promised.They have had my knee for over two months now and have not provided update.The anti stumble feature is garbage and should be investigated.I have fallen many times because of this: in driveway, house, stairs etc.Now from the fall i am having problems with my limb and have to return to the trauma surgeon.The limb has had sharp pain in it since the fall.I live alone, so i was on crutches or in a wheelchair until the replacement was sent.Please investigate my claim.Ottobock has my knee and i am sure they have extensive information from the computer.

Event Description

Additional information received from reporter on 10/27/2020 for mw5083730.Fall down stairs.I have an ottobock x3 knee unit and this is my second complaint with fda.The knee unit was leaking hydraulic fluid and failed.The lack of hydraulic fluid caused me to fall hard down steps.When i took the knee unit to (b)(6), ottobock failed to warranty or stand behind their product.I had to spend over (b)(6) to fix the knee unit myself.The knee unit was replaced in 2018 for the same issue and the warranty should have been carried through 2021.Ottobock failed to warranty their product and has not addressed the hydraulic fluid issue.My new prosthetist is at (b)(6) in (b)(6).Prosthetist did an exam of knee and said it was broken and unusable.Fda safety report id# (b)(4).

• Brand Name: OTTOBOCK X3 KNEE UNIT
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL
• Manufacturer (Section D): OTTOBOCK SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCARE
• MDR Report Key: 8310703
• MDR Text Key: 135881491
• Report Number: MW5083730
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2021
• Device Model Number: I DO NOT HAVE THE KNEE ANYMORE
• Device Catalogue Number: I DO NOT HAVE THE KNEE ANYMORE
• Device Lot Number: I DO NOT HAVE THE KNEE ANYMORE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 109