MAUDE Adverse Event Report: SMITH&NEPHEW, INC BICON-PLUS; FEMORAL COMPONENT SHELL

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that a revision was performed due to loosening.

• Brand Name: BICON-PLUS
• Type of Device: FEMORAL COMPONENT SHELL
• Manufacturer (Section D): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; GM CH5000
• Manufacturer Contact: phillip emmert ; 1450 e brooks rd; memphis, TN 38116 ; 9013995296
• MDR Report Key: 3770405
• MDR Text Key: 4446290
• Report Number: 9613369-2014-00062
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/24/2014
• Is the Device Single Use?: Yes
• 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