MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 3 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420116
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revsion surgery was perfomed due to loosening of the femoral component.Devices revised to legion components.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GEN II COCR PS NP FEMORAL COMPSZ 3 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7916899
• Report Number: 1020279-2018-01930
• Device Sequence Number: 16720652
• Product Code: JWH
• UDI-Device Identifier: 03596010206022
• UDI-Public: 03596010206022
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Catalogue Number: 71420116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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: PARTS:71420180,71421502,71420576
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention