MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OR71421539
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to system infection.There was washout and poly exchange of right knee.No delay reported and backup was not needed.
Additional Manufacturer Narrative
The associated genesis ii deep dished flexion insert was not returned for evaluation.A clinical evaluation noted that no additional clinical documents are available at this time.Therefore, no thorough clinical assessment of the reported issue can be rendered.There is no evidence to support our device contributed to the reported infection.Our investigation including a review of the manufacturing records for the listed insert with the listed batch 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 failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 15M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8146007
• Report Number: 1020279-2018-02719
• Device Sequence Number: 2112561
• Product Code: JWH
• UDI-Device Identifier: 03596010520425
• UDI-Public: 03596010520425
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: No Information
• Device Expiration Date: 07/29/2022
• Device Model Number: OR71421539
• Device Catalogue Number: OR71421539
• Device Lot Number: 12GM16768
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420184 /71420578 /71420150