MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG COMPACT KNEE JOINT; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C96-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

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

No failure of the device.Stump fluctuations caused insufficient grip of the prosthesis.No technical problems with the fittings.Loss of adhesion between liner and shaft, which led to internal rotation of the prosthesis in the swing phase.

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.The device passed all tests after a correct zero setting.According to the event description and in accordance with the results of the device investigation the user has fallen due to a loss of adhesion between the liner and the shaft.Thus the device can be excluded as the root cause which may have caused or contributed to the occurred event and the only reason for the event is an erroneous shaft assembly.

• Brand Name: C-LEG COMPACT KNEE JOINT
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 8988846
• MDR Text Key: 157356550
• Report Number: 9615892-2019-00013
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C96-1
• Device Catalogue Number: 3C96-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 55