MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ6 LT; PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	71421236
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to extremely unstable primary total knee replacement.
Additional Manufacturer Narrative
Additional info: the associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.

• Brand Name: LEGION CR OXIN FEM SZ6 LT
• Common Device Name: PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7134177
• Report Number: 1020279-2017-01301
• Device Sequence Number: 1290334
• Product Code: JWH
• UDI-Device Identifier: 00885556030202
• UDI-Public: 00885556030202
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 03/19/2020
• Device Catalogue Number: 71421236
• Device Lot Number: 10CM13501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/27/2018
• 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: Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 89