MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	71453201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to set the nail due to fracture of femoral, the new insert was not inserted into the implanted old baseplate.Therefore the surgeon set the old insert again.
Additional Manufacturer Narrative
Please review attached for investigation results.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6878650
• Report Number: 1020279-2017-00765
• Device Sequence Number: 656762
• Product Code: JWH
• UDI-Device Identifier: 00885556033784
• UDI-Public: (01)00885556033784(17)251008(10)15KT59987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 12/01/2017

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: No Information
• Device Expiration Date: 10/08/2025
• Device Model Number: 71453201
• Device Catalogue Number: 71453201
• Device Lot Number: 15KT59987
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 12/01/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR