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

Model Number 3C60=A

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 09/30/2022

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

Incorrect joint behavior - the patient walked around the car and the joint went free and the patient fell.He didn't get stuck anywhere or anything like that.Fall!! patient fell and lacerated his hand.This had to be sewn.End of september.

Manufacturer Narrative

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

• 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: 15637394
• MDR Text Key: 302056175
• Report Number: 9615892-2022-00013
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C60=A
• Device Catalogue Number: 3C60=A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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: Male
• Patient Weight: 63 KG