MAUDE Adverse Event Report: OSSUR HF ICEROSS DERMO LOCKING; LINER

Model Number I-431326

Device Problems Insufficient Information (3190); Misassembled During Installation (4049)

Patient Problem Limb Fracture (4518)

Event Type  Injury  

Event Description

Patient fell due to an issue with the prosthesis and fractured the tip of the bone in the stump.

Event Description

Patient fell due to an issue with the prosthesis and fractured the tip of the bone in the stump.

Manufacturer Narrative

The user reported that the pin broke and that is a part of a lock from another manufacturer.Unable to confirm if the liner failed since it was not returned.

• Brand Name: ICEROSS DERMO LOCKING
• Type of Device: LINER
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, ; IC
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 18738668
• MDR Text Key: 335751749
• Report Number: 3003764610-2024-00001
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I-431326
• Device Catalogue Number: I-431326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male