MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to suspected patellar clunk syndrome.Insert replacement and soft tissue resection were conducted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it has been communicated that no additional clinical documents are available at this time.Therefore, no thorough clinical assessment of the reported issue can be rendered.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8209116
• Report Number: 1020279-2019-00006
• Device Sequence Number: 277082
• Product Code: JWH
• UDI-Device Identifier: 00885556033784
• UDI-Public: 00885556033784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/29/2019

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: Health Professional
• Device Catalogue Number: 71453201
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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