MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420766
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Poly was exchanged.Device will not be returned.Xrays not available.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.Poly was exchanged.The associated genesis ii dished insert, used in treatment, was not returned for evaluation.Thus the product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The devices was sterilized according to sterilization release documentation from quality control.A relationship, if any, between the device and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.Per our risk assessment, possible causes could include but not limited to contamination, patient reaction or post-operative healing issue.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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 DISHED INS SZ 3-4 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9199341
• Report Number: 1020279-2019-03665
• Device Sequence Number: 13565346
• Product Code: JWH
• UDI-Device Identifier: 03596010209320
• UDI-Public: 03596010209320
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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 Model Number: 71420766
• Device Catalogue Number: 71420766
• Device Lot Number: 18BM12708
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1