MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II POROUS P/S FEM SZ7 LT; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR

Model Number	71420874
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported twelve years after implantation revision surgery was performed due to instability.Upon inspection, the femoral component appeared pristine like new.But, post on the ps poly was broken.All pieces were recovered.Customer is requiring an analysis of both structural integrity and volumetric wear.

• Brand Name: GNS II POROUS P/S FEM SZ7 LT
• Common Device Name: PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9833779
• Report Number: 1020279-2020-00849
• Device Sequence Number: 3129890
• Product Code: JWH
• UDI-Device Identifier: 03596010209849
• UDI-Public: 03596010209849
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: 71420874
• Device Catalogue Number: 71420874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1