MAUDE Adverse Event Report: MAXHEALTH CORPORATION PROBASICS; KNEE WALKER

Model Number PB1030KW

Device Problem Solder Joint Fracture (2324)

Patient Problem Limb Fracture (4518)

Event Date 12/14/2018

Event Type  Injury  

Event Description

On march 5, 2020 chb was notified of the following: consumer was using the knee walker in the manner that it was intended to be used, the front wheel assembly malfunctioned causing the end-user to fall and to be seriously injured.The device was rented.The end-user was recovering from foot surgery.Failed to provide a necessary weld on the front wheel assembly of the walker which created a condition whereby the knee walker would fail when put to its intended use.On march 18, 2022 chb was notified of the following: i am not a doctor, but it is my understanding that i suffered a fractured left arm characterized as a left olecranon fracture that required an open reduction and internal fixation, a laceration on my left knee and bruising to my forehead.He has been treated for diabetes for 15 years.Had a knee replacement surgery in 2007.Bariatric surgery in 2016.On (b)(6) 2018 he underwent reconstructive surgery for charcot foot.He wears bifocals.He was wearing no shoes at the time of occurrence.He was not carrying anything.He was in the hallway adjacent to the bathroom in his apartment.He was two feet from the hallway wall, where he hit his head at the time of the fall.He has ongoing pain/stiffness with reduced range of motion in the left arm caused by broken ulna.Sensitivity to cold, numbness, severe pain at times.Ongoing checkups with surgeon, treatment for pain by primary physician.He states 94 photographs were taken of the walker taken by esi, plaintiffs' engineering expert, that were produced by plaintiffs on (b)(6) 2020, and see plaintiffs' document production for 11 photographs taken by plaintiffs.Per fire dept.Report: the pt reported tripping in the bathroom and falling on to his left elbow and knee.The pt added that he did hit his head but had no loc, no head, neck or back pain, bno cp, sob or dizziness - no blood thinners.The pt was found with pain and limited mobility in the left elbow and a laceration to the lower left leg.The pt added that he had foot surgery 10 days ago.Narrative: pt found sitting in chair.Pt had previous surgery to l ankle and had his foot wrapped in soft cast limiting his mobility.Pt stated he tripped coming out of bathroom landing on his l knee and elbow.Pt had small lac to l knee bleeding controlled and swelling to l elbow.Per deposition: i am 6 foot 5.He states he does not know if it came assembled or not, when he saw it, it was assembled (wife picked up device).He states no user manual and was not aware the weight limit was 300 lbs.He was not aware the height limit was 5 foot 10.He did not inspect the device before use.He was not wearing shoes, was wearing hospital-provided socks with the traction.He states: "i was exiting the bathroom.As i was turning slightly to the right, it turned further in the wheel span to turn to a 90-degree angle from where it was positioned.I was going to the right, and i was thrown to the left because of the instability of the scooter." on december 18 he was doing physical therapy when he felt a pop in his elbow which required a revision surgery on december 19.After that surgery he was discharged for acute rehabilitation at a facility (he stayed 2 hours) and left because he felt they did not meet his needs.He states the oversteering mechanism broke off at the time of the fall.That "it made a high-pitched tinkling noise and was underneath me." he states he was "unaware of the piece" existing on the device.Only (b)(6) 2021, he had another elbow surgery.He states: "i have what would appear to be nerve damage pain because of the threading of the nerve through that central location and a bone that had grown, a bone mass or a calcium mass that had grown at the back of the elbow, and they went in to remove that and to remove the hardware that they had installed on the first operation." he takes pain medications and undergoes pt and ot.He states he adjusted the height of the handlebars himself.Attached: user manual.Page 2, save these instructions: note: dealer-these instructions must be given to the user of this product.Page 2, patient height specification & maximum weight: model: 1030, patient height min./max: 5'2" - 5'10", maximum weight: 300 lbs.Page 2, warning: a physical/occupational therapist should assist in the height adjustment of the knee walker for maximum support.Attached: photo.Picture is a close-up of the probasics sticker on the frame of the device (provided by initial reporter).It shows "probasics, 1030, barcode, 1030 1016en000156, weight capacity: 300 lbs.(136 kgs), made in (b)(4).The end-user is just under the maximum weight capacity of 300 lbs., but is over the maximum height limit of 5'10".

• Brand Name: PROBASICS
• Type of Device: KNEE WALKER
• Manufacturer (Section D): MAXHEALTH CORPORATION; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, taipei ; TW
• MDR Report Key: 13839888
• MDR Text Key: 287539895
• Report Number: 3012316249-2022-00005
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

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 Model Number: PB1030KW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2022
• Distributor Facility Aware Date: 03/18/2022
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 03/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 132 KG