MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR 260BW 30 CAL SZ 12L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71340812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a dislocation.An aspiration was performed and an infection was found.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The device was manufactured in 2009.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: patient had a left hip replacement in 2009 due to arthritis.It was reported that a revision surgery was performed 2018 due to a dislocation.An aspiration was performed and an infection was found; however, no medical imaging, lab values or laboratory results were provided.To date no medical records have been received on this complaint.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event medical/clinical records are received, this complaint will be re-evaluated and a thorough medical assessment rendered.A root cause could not be determined at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ECH POR 260BW 30 CAL SZ 12L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9712760
• Report Number: 1020279-2020-00550
• Device Sequence Number: 2512966
• Product Code: JDI
• UDI-Device Identifier: 03596010383983
• UDI-Public: 03596010383983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 04/14/2019
• Device Model Number: 71340812
• Device Catalogue Number: 71340812
• Device Lot Number: 09DM11378
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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