MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420754
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the possibility of infection.After the revision, it was realized that the patient has not been suffered from the infection.The insert seemed to be covered with the some forms.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis and the component was inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.A tibial insert and three screws were retrieved.The insert is worn and discolored.The periphery and locking detail are damaged.The screws are intact with scratches on the top, likely due to insertion and removal.There were no observations of material or manufacturing deviations in the course of this investigation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII DISHED INS SZ1-2 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: 8727664
• Report Number: 1020279-2019-02439
• Device Sequence Number: 14008438
• Product Code: JWH
• UDI-Device Identifier: 03596010209269
• UDI-Public: 03596010209269
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: Health Professional
• Device Expiration Date: 03/29/2018
• Device Catalogue Number: 71420754
• Device Lot Number: 08CT17919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/02/2019
• Supplement Date Received by Manufacturer: 06/02/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER 71420974 / LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention