MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 RIGHT; PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMETALPOLYMER

Model Number	71420188
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed due to the progression of patello femoral osteoarthritis as a treatment.

• Brand Name: GNS II CMT TIB SIZE 6 RIGHT
• Common Device Name: PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9880407
• Report Number: 1020279-2020-01011
• Device Sequence Number: 16904347
• Product Code: JWH
• UDI-Device Identifier: 03596010206367
• UDI-Public: 03596010206367
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2020

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: 71420188
• Device Catalogue Number: 71420188
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 12/24/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 82