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

Model Number 3B5-2=S

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/14/2019

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

During the service, adjustments with the genium x3 a fall occured.As a result of the fall, a fracture in the right ankle joint occurred which had to be treated surgically.According to the user, she went on level gravel surface, the knee joint suddenly and unexpectedly blocked.By blocking of the joint, it came immediately to the fall.The knee joint was installed according to the manufacturer's instructions and the parameters corresponded to those of the user's knee joint in service.Statics, dynamics and the function of the prosthesis were checked before delivery of the service joint and were alright.

• 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: 8353297
• MDR Text Key: 136590903
• Report Number: 9615892-2019-00003
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3B5-2=S
• Device Catalogue Number: 3B5-2=S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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 Age: 40 YR
• Patient Weight: 56