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); Bone Fracture(s) (1870); Damage to Ligament(s) (1952); Insufficient Information (4580)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to both occurred events in (b)(6) 2022.

Event Description

Initial information received on 10/12/2022: incorrect behavior - knee locking up and buckling at inappropreiate times.The patient was in her kitchen and the knee buckled, she fell over and hit her kitchen counter.She did seek medical attention, and was told she has a torn rotary cuff.Pt also had the knee buckle on her and she hit her hip on following information received by healthcare professional on (b)(6) 2022 : (b)(6) 2022 fall: - patient was in bathroom, stood and went to turn and felt knee give away, partially caught herself on counter - resulted in: full thickness/full width supraspinatus and infraspinatus tendon tearing (torn rotator cuff, determined by mri) (b)(6) 2022 fall: - bathroom, stood from toilet and went to start walking to sink, took one step and knee buckled/gave away and she fell to floor - no known injuries, however, had mri this week to assess occult fracture (in hip) following information received by healthcare professional after request for further information by manufacturer on (b)(6) 2022 : (b)(6) 2022 fall: - the rotator cuff tear did not lead to a surgery and the only treatment to date is occupational/physical therapy.Surgeon did not want to perform surgery at this time.- patient's husband (of 60yrs) was having serious health conditions and then passed away, therefore, the fall was not reported immediately.- patient reported it was the knee bending when it was not suppose to; there was no report of wet floors or other external circumstances.(b)(6) 2022 fall: - there is possibly an injury from the fall; patient was having further imaging done to determine if there was a fracture from the fall.(orthopedic doctor dictated there was a chance of fracture (occult fracture - one that is not readily visible on the x-ray).Patient was having mri completed to determine if there is an injury.I have not heard results from the imaging.Patient also stated she felt knee has buckled/gave way in 2-3 other instances while she was ambulating in the community (i.E.Walking into dentist, at grocery store), however, she did not fall/she was able to catch herself.She also reported the wheelchair function was not staying locked on occasion.

• 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: 15978835
• MDR Text Key: 305490332
• Report Number: 9615892-2022-00021
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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): Required Intervention; Hospitalization
• Patient Sex: Female