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

Catalog Number	71330001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove all the parts due to infection.
Additional 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
• Common Device Name: PRSTHSS,HIP,SMICNSTRND,UNCMNTD,MTAL/POLYMER,PROS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7104645
• Report Number: 1020279-2017-01220
• Device Sequence Number: 19301412
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 01/29/2023
• Device Catalogue Number: 71330001
• Device Lot Number: 13AM18509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 04/04/2018
• 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