MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION; FEMORAL COMPONENT

Catalog Number 71742854

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 01/07/2014

Event Type  Injury  

Manufacturer Narrative

This complaint return has several features which could not be accuracy measure because of damage and out of roundness to the liner.Any evaluation of the part would be inconclusive.Also visual evaluation of one of the liners identified the laser etch to be partially diminished.This condition is commonly seen after parts have been autoclaved, a process that will physically change the part size.The shell was also checked dimensionally and found to meet the print specifications.

Event Description

It was reported that surgery was delayed due to the seating of the device.A second device was used successfully to complete the surgery.

• Brand Name: REFLECTION
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 3608672
• MDR Text Key: 11750005
• Report Number: 1020279-2014-00069
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71742854
• Device Lot Number: 12EM13323
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/22/2014
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR