MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF MODULAR STEM WITH STIKTITE SZ 3; HIP IMPLANT

Catalog Number 71352503

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to septic loosening.

Manufacturer Narrative

• Brand Name: SMF MODULAR STEM WITH STIKTITE SZ 3
• 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: commie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3875508
• MDR Text Key: 4511538
• Report Number: 1020279-2014-00372
• 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,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 71352503
• Device Lot Number: 13EM08541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR