MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453202
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery will be performed due to fall of the patient, causing a disassociation of the device.
Additional Manufacturer Narrative
The associated legion ps high flexion insert was returned and evaluated.From the lab analysis conducted during this investigation, it was concluded that the exact cause of the post wear and deformation, lock detail deformation and fracture, and the small anterior notch or gouge could not be determined.There were no observations of material or manufacturing deviations in the course of this investigation.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the available information, the cause of the wear damage on the insert could not be concluded.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.No further medical assessment can be rendered at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 11MM
• 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: 7711422
• Report Number: 1020279-2018-01351
• Device Sequence Number: 11455888
• Product Code: JWH
• UDI-Device Identifier: 00885556034316
• UDI-Public: 00885556034316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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 Expiration Date: 09/08/2025
• Device Catalogue Number: 71453202
• Device Lot Number: 15JT58728
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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