MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	71453121
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that doctor removed a gii knee from patient due to infection.
Additional Manufacturer Narrative
The affected legion cr high flexion insert, legion ha porous cr femoral component, genesis ii np tibial baseplate and genesis ii resurfacing patellar component were not returned for evaluation.The devices were manufactured in 2014 and 2015.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.Products were sterilized according to sterilization release documentation from quality control.A clinical evaluation noted that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no clinical assessment can be performed at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 9MM
• Common Device Name: PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8071185
• Report Number: 1020279-2018-02483
• Device Sequence Number: 16533514
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 71453121
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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: Other; Required Intervention