MAUDE Adverse Event Report: SMITH & NEPHEW, INC. M-COR FEMORAL NECK; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 03/07/2016

Event Type  Injury  

Event Description

It was reported a revision hip surgery was performed due to a fractured femoral neck.The neck and stem were removed during the revision surgery.

Manufacturer Narrative

Following receipt of additional information concerning this case it has been determined that the initial report was submitted in error.This device is not manufactured of distributed by smith & nephew.Please therefore disregard this report.(b)(4).

• Brand Name: M-COR FEMORAL NECK
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6959261
• MDR Text Key: 89640993
• Report Number: 1020279-2017-00885
• 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,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: M-COR FEMORAL STEM
• Patient Outcome(s): Hospitalization; Required Intervention