MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71424004
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a legion revision tka surgery on (b)(6) 2020 it was implanted a legion tibial base plate.When surgeon was attempting to insert the 3-4 13mm constrained poly it would not lock down.A second high flex legion poly was opened and attempted to be inserted in and would not lock in as well.Each poly was inserted multiple times and popped out with a instrument with minimum anterior pressure.It was then decided after several attempts to leave the constrained insert in due to the tibial base plate being cemented.Knee seemed stable without the poly moving.A delay greater than 30 min was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident some potential causes of the reported event could include but are not limited to surgical technique used, or size of device.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 could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN REV TIBIA BASE SZ 4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10279601
• Report Number: 1020279-2020-03226
• Device Sequence Number: 16797515
• Product Code: JWH
• UDI-Device Identifier: 03596010546081
• UDI-Public: 03596010546081
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71424004
• Device Catalogue Number: 71424004
• Device Lot Number: 18KM18271
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1