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

Catalog Number 71356004

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 06/20/2014

Event Type  Injury  

Event Description

It was reported that surgery was delayed, due to the device subsiding upon implantation.Therefore, the surgeon implanted a device two sizes larger.

Manufacturer Narrative

Manufacturer Narrative

The part was evaluated and found to be within specifications.

• Brand Name: ANTHOLOGY
• 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: 3900727
• MDR Text Key: 4653678
• Report Number: 1020279-2014-00384
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 71356004
• Device Lot Number: 14EM05239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Date Manufacturer Received: 06/20/2014
• 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