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

Catalog Number	71453202
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a delay greater than 30 minutes occurred during surgery due to the insert not locking on the tibial baseplate.
Additional Manufacturer Narrative
The affected legion ps xlpe high flexion insert was returned and evaluated.Our investigation included a lab analysis which indicated a deformation of the anterior face and anterior locking mechanism of the insert.The deformation to the anterior face was likely due to impact force during insertion or extraction.The posterior locking detail appears to never have been engaged with the tibial baseplate tray.No manufacturing deviations were noted during this investigation.Based on the investigation conducted, the exact cause of the insert not locking with the tibial tray was not able to be determined.A clinical evaluation noted there is an insufficient relevant documentation provided to perform a thorough medical investigation.However, it was reported that no harm/patient injury resulted from the 60 minute surgical delay.No further medical assessment is warranted at this time.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 part revealed no prior complaints for the listed 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.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 1-2 11MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7305783
• Report Number: 1020279-2018-00255
• Device Sequence Number: 16458945
• Product Code: JWH
• UDI-Device Identifier: 00885556034316
• UDI-Public: 00885556034316
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/02/2018

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: 71453202
• Device Lot Number: 17GT90158
• Initial Date Received by Manufacturer: 02/10/2018
• Supplement Date Received by Manufacturer: 02/10/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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: Other