MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PRSTHSS,HIP,SMICNSTRND,UNCMNTD,MTAL/POLYMER,PROS

Catalog Number 71330001

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to remove all the parts due to infection.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, this is a complaint from (b)(6) reporting a revision of a reflection hip secondary to an infection was performed on (b)(6) 2017.All the components were removed.It was communicated that no further information would be forthcoming.No date for the primary surgery was provided.No clinical/medical documents, x-rays nor, operative reports were provided.Based on the lack of information, an investigation cannot be completed and the root cause of the infection cannot be concluded.No patient information has been presented at this time.Should any relevant information become available this complaint can be re-assessed.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.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.We consider this investigation closed.

• Brand Name: REF INTERFIT THRD HOLE COVER
• Type of Device: PRSTHSS,HIP,SMICNSTRND,UNCMNTD,MTAL/POLYMER,PROS
• 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
• MDR Report Key: 7104645
• MDR Text Key: 94403164
• Report Number: 1020279-2017-01220
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 71330001
• Device Lot Number: 13AM18509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2013
• 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