MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453223
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision tkr was performed to resurface a patella that had not been replaced on primary tkr, ( primary tkr performed 7years ago), poly was exchanged whilst performing the revision surgery, poly noted to have unusual wear pattern and yellow staining.The surgeon requested the poly be sent for investigation of the staining and wear pattern to detect any abnormalities.
Additional Manufacturer Narrative
It was reported that a revision tkr was performed to resurface a patella.Poly was exchanged whilst performing the revision surgery.Poly noted to have unusual wear pattern and yellow staining.The associated patellar component and the reported insert (part number 71453223 legion insert) were not returned.The returned part was a genesis ii high flexion insert, part number 71421517.Thus, an evaluation was conducted on the returned part.A lab analysis conducted during this investigation noted that the articulating and non-articulating surfaces of the poly insert are worn with discoloration.The discoloration is most likely attributed to lipid absorption.The locking detail has some debris in it.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 insert with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the insert revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted that the patient impact beyond the revision procedure itself is not anticipated as no patient injury/harm was reported.No further medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 13MM
• 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: 9161743
• Report Number: 1020279-2019-03561
• Device Sequence Number: 11300678
• Product Code: JWH
• UDI-Device Identifier: 00885556033425
• UDI-Public: 00885556033425
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: 71453223
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1