MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S7-8 9MM; PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	71421547
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a washout was performed due to infection, the insert was changed.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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 part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.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.

• Brand Name: GII CR DEEP FLEX ISRT S7-8 9MM
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7528651
• Report Number: 1020279-2018-00969
• Device Sequence Number: 13877824
• Product Code: JWH
• UDI-Device Identifier: 03596010512505
• UDI-Public: 03596010512505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2018

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: 06/04/2023
• Device Catalogue Number: 71421547
• Device Lot Number: 13FM03931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/20/2018
• Supplement Report FDA Received Date: 07/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR