MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF MODULAR STIKTITE SZ1; HIP IMPLANT

Catalog Number OR71352501

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 03/27/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to thigh pain.

• Brand Name: SMF MODULAR STIKTITE SZ1
• 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 ; 9013985146
• MDR Report Key: 3715317
• MDR Text Key: 16010073
• Report Number: 1020279-2014-00210
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2014

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
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: OR71352501
• Device Lot Number: 12FM13110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 03/31/2014
• Date Device Manufactured: 06/01/2012
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR