MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED; LEGION CR OXIN FEM SZ7 LT

Model Number	71421237
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision took place due to a failed total knee arthroplasty.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

• Brand Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Common Device Name: LEGION CR OXIN FEM SZ7 LT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6597602
• Report Number: 1020279-2017-00373
• Device Sequence Number: 91874
• Product Code: JWH
• UDI-Device Identifier: 00885556030486
• UDI-Public: 00885556030486
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 06/12/2020
• Device Model Number: 71421237
• Device Catalogue Number: 71421237
• Device Lot Number: 10FM08915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 10/13/2017
• 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: 71420170, LOT: 10AT39002, GNS II CMT TIB SIZE 6 {}; 71420778, LOT: 07GM02469, GII DISHED INS SZ 5-6 9M
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 111