MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 21; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421513
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision of total knee system due to second disengagement of tibial poly insert.First disengagement occured some 6 months post implantation, caused by the fall and only saw tibial insert replaced.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 21
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6746312
• Report Number: 1020279-2017-00563
• Device Sequence Number: 220145
• Product Code: JWH
• UDI-Device Identifier: 03596010493811
• UDI-Public: 03596010493811
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 03/09/2023
• Device Model Number: 71421513
• Device Catalogue Number: 71421513
• Device Lot Number: 13CM06949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 11/07/2017
• 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: GII OXIN P/S FEM RIGHT SZ 6, 71421116 / 16AM14529; GNS II CMT TIB SIZE 4 RIGHT, 71420184 / 15HT57649
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention