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

Catalog Number	71291101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from pain and the emperion implant fracture was confirmed.Revision surgery was performed.
Additional 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
• Common Device Name: PROSTHESS,HIP,SMICONSTRAIND,UNCMNTD,METL/POLYMR,NONPOROS,CALICMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis; TN 38116
• MDR Report Key: 7688585
• Report Number: 1020279-2018-01296
• Device Sequence Number: 16789247
• Product Code: MEH
• UDI-Device Identifier: 03596010561374
• UDI-Public: 03596010561374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2024
• Device Catalogue Number: 71291101
• Device Lot Number: 14DM23192
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention