MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NON STRL VISIONAIRE RT CUT BLK KIT LGNP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	V0200023
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report being re-submitted on 7/13/2017 following failed submission on 7/12/2017 due to exceeding maximum character count.
Event or Problem Description
It was reported that the cutting block produced, was apparently well positioned in the bone when used.After that, the surgeon performed a severe anterior notching in the femur, considering the final position dictated by the cutting block.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: NON STRL VISIONAIRE RT CUT BLK KIT LGNP
• 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: 6709770
• Report Number: 1020279-2017-00522
• Device Sequence Number: 2064483
• Product Code: JWH
• UDI-Device Identifier: 00885556583074
• UDI-Public: 00885556583074
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 04/20/2017
• Device Model Number: V0200023
• Device Catalogue Number: V0200023
• Device Lot Number: 00070925V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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: Disability
• Patient Age: 65 YR