MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY SO; PROSTH, HIP, SEMI-CONS, UNCEM, METAL/POLY, NON-PORO, CALICUM-PHOSPH

Model Number	71291301
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an emperion stem failure.The surgeon applied a bending force as would be present with weightbearing and felt that he could see a small amount of gapping and opening at the lateral aspect of the stem consistent with a fatigue failure.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the root cause of the reported stem cracking cannot be concluded with the provided information.The stem was not returned for our examination.What was reported as a stem failure as a root cause of the revision cannot be concluded as the report of possible stem cracking was recognized at the conclusion of the procedure.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation indicated that the root cause of the reported stem cracking cannot be concluded with the provided information.The stem was not returned for our examination.What was reported as a stem failure as a root cause of the revision cannot be concluded as the report of possible stem cracking was recognized at the conclusion of the procedure.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.No further actions are being taken at this time.

• Brand Name: EMP 13 STEM PRIMARY SO
• Common Device Name: PROSTH, HIP, SEMI-CONS, UNCEM, METAL/POLY, NON-PORO, CALICUM-PHOSPH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9633877
• Report Number: 1020279-2020-00393
• Device Sequence Number: 14314020
• Product Code: MEH
• UDI-Device Identifier: 03596010561480
• UDI-Public: 03596010561480
• 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: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/26/2021

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: 04/07/2020
• Device Model Number: 71291301
• Device Catalogue Number: 71291301
• Device Lot Number: 10GM02865
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 11/10/2020; 08/25/2021
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/24/2020; 11/12/2020; 08/26/2021
• 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