MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71421214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient has experienced redness, swelling and more pain than experienced with her original knee that was replaced.Another surgery is needed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the available information, the revision was precipitated by the painful arthrofibrosis documented in both interventions.The arthrofibrosis/scar tissue in some cases occurs after surgery and is most likely the root cause in this instance and not a failure of the prosthesis.No information on the patient's current status has been provided.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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.We consider this investigation closed.

• Brand Name: LEGION PS OXIN FEM SZ4 LT
• 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: 7528840
• Report Number: 1020279-2018-00974
• Device Sequence Number: 1898182
• Product Code: JWH
• UDI-Device Identifier: 00885556029121
• UDI-Public: 00885556029121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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 Catalogue Number: 71421214
• Device Lot Number: 16CM03142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 09/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention