MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 11 STEM PRIMARY SO; PROSTHESS,HIP,SMICONSTRAIND,UNCMNTD,METL/POLYMR,NONPOROS,CALICMPHOSPHATE

Catalog Number 71291101

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 08/19/2016

Event Type  Injury  

Event Description

It was reported that the patient suffered from pain and the emperion implant fracture was confirmed.Revision surgery was performed.

Manufacturer Narrative

The device was not evaluated due to no sample was returned for investigation.Investigation results: the associated complaint devices were not returned.The clinical/medical team concluded, several attempts have been made to obtain clinical/medical documents to no avail at this time.The communication will be through the legal department. when the medical records become available this complaint will be re-opened and thorough investigation will be performed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: EMP 11 STEM PRIMARY SO
• Type of Device: PROSTHESS,HIP,SMICONSTRAIND,UNCMNTD,METL/POLYMR,NONPOROS,CALICMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis; TN 38116
• Manufacturer (Section G): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7688585
• MDR Text Key: 114005772
• Report Number: 1020279-2018-01296
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561374
• UDI-Public: 03596010561374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: 04/27/2024
• Device Catalogue Number: 71291101
• Device Lot Number: 14DM23192
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/15/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention