MAUDE Adverse Event Report: SMITH AND NEPHEW PROFIX

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 10/28/2013

Event Type  Injury  

Event Description

Aseptic loosening within six months after installation surgery.No indication of an infection.Prosthesis was manufactured by smith and nephew and the model name is profix.

• Brand Name: PROFIX
• Type of Device: PROFIX
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 3973004
• MDR Text Key: 4753319
• Report Number: MW5037532
• Device Sequence Number: 1
• Product Code: HSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 127