MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH GENIUM X3; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3B5-2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Knee does not function well.No resistance during walking.Reset the knee did not help.Patient has been in hospital for one week after treatment.His arm was swollen like a sausage due to inflammation of a hematoma.He also had a rupture of the m.Supra spinatus and a rupture of m.Biceps left, probably he will have to undergo surgery again to recover m.Biceps.Mri has not yet decided if that is necessary (receives mri scan within 6 weeks).Range of motion of shoulder is also limited to 45 degrees.

• Brand Name: GENIUM X3
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7663461
• MDR Text Key: 113170760
• Report Number: 9615892-2018-00018
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B5-2
• Device Catalogue Number: 3B5-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2018
• 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): Hospitalization; Required Intervention
• Patient Weight: 95