MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD HIGH OFFSET NEUTRAL MODULAR NECK; HIP IMPLANT

Catalog Number 71352112

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Swelling (2091); Test Result (2695)

Event Date 08/05/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to high metal ion levels and a pseudo-tumor around the femur.

Manufacturer Narrative

• Brand Name: STANDARD HIGH OFFSET NEUTRAL MODULAR NECK
• Type of Device: HIP IMPLANT
• 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: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3994861
• MDR Text Key: 18926033
• Report Number: 1020279-2014-00490
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71352112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR