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

Catalog Number 71352503

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 06/23/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain and high metal ion levels.

• 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: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3929407
• MDR Text Key: 4668377
• Report Number: 1020279-2014-00407
• 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: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 71352503
• Device Lot Number: 11BM09746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2014
• Date Device Manufactured: 02/01/2011
• 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) -LOT 10MTM0004A, (B)(4) - LOT 11CM13363
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100