MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453222
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a medical intervention in which it was required to aspirate the left knee to prevent infection in the periprosthetic area.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches 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 failure mode with the same batch number.The devices were manufactured in 2015 and 2016.A clinical analysis noted that based on the information provided, the only product failure, noted in the long list of unfortunate events, was for the second revision on (b)(6) 2018.The procedure notes documented ¿mechanical complications of device with failure of fixation mechanism ¿ arthrofibrosis with severe range of motion limitation ¿ failure of the anterior locking component of the tibial poly insert and tibial base plate.The root cause of this failure cannot be concluded, however the documented arthrofibrosis cannot be excluded as a contributing factor.No current or updated information regarding the patient¿s current status has been provided at this time.Products were sterilized according to sterilization release documentation from quality control.Without the return of the actual product involved, our investigation of this report is inconclusive.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 PS HIGH FLEX XLPE SZ 5-6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7930808
• Report Number: 1020279-2018-02008
• Device Sequence Number: 2064182
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

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: 71453222
• Device Lot Number: 16KT177148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 12/07/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/07/2018; 12/17/2018
• 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