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

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to periprosthetic fracture with stem subsidence.The patient had an emergency surgery in the end of (b)(6) 2014 with a screwed plate for a periprosthetic fracture (the patient fell).This fracture led to the sl-plus stem loosening (implanted 9 years).

Manufacturer Narrative

• Brand Name: SL-PLUS
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer Contact: phillip emmert ; 1450 e. brooks rd; memphis, TN 38116 ; 9013995296
• MDR Report Key: 3977454
• MDR Text Key: 4749653
• Report Number: 9613369-2014-00081
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/31/2014

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: 07/09/2014
• Initial Date FDA Received: 08/04/2014
• 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