MAUDE Adverse Event Report: SMITH & NEPHEW, INC LEGION PS OXIN FEM SZ7 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421207
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The root causes of the pain and instability suffered by this patient were likely long term results from the damage to the knee from the gunshot wound, which resulted in "severe dystrophic bone and deformity" and in multiple knee procedures with some prior to the noted (b)(6) 2015 implant of s&n product.Noted is that no mention of a "loose hinge and broken hardware" was documented in the operative notes and the current implants are not smith and nephew products.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/failure mode.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.
Event or Problem Description
It was reported that a revision surgery was performed due to instability.

• Brand Name: LEGION PS OXIN FEM SZ7 RT
• 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: 7815130
• Report Number: 1020279-2018-01629
• Device Sequence Number: 19210944
• Product Code: JWH
• UDI-Device Identifier: 00885556029404
• UDI-Public: 00885556029404
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 71421207
• Device Lot Number: 12LM06610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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: Hospitalization; Required Intervention