MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH KENEVO; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C60

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Hematoma (1884); Injury (2348)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation (not returned from the customer yet); supplemental report will be submitted after additional information has been obtained.

Event Description

The kenevo came back 01.03 in ob (b)(4) with no previous notice.Patient fell on (b)(6) going down the stairs at home; he had been equipped for 3 weeks with the kenevo (2 weeks in b+ and one in c).The knee didn't lock and the patient mentions "it was like putting my foot in a hole".Patient went to (b)(6) hospital for xrays and skin care.Body damages : brachial and costal hematomas and light wounds on arm.

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 ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 8407023
• MDR Text Key: 138358636
• Report Number: 9615892-2019-00004
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 03/14/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization