MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 3 L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Catalog Number	71933569
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a tka procedure, instead of opening a legion tib base w/journey lock size 3 l, surgeons used a legion primary baseplate.Then realized, they had to open revision instrumentation in which revised the tibial base plate to a legion revision baseplate with journey lock mechanism a new poly and a short stem.There was a slightly delay, and there was a change in the surgical technique.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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: LEGION TIB BASE W/JOURNEY LOCK SZ 3 L
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11610803
• Report Number: 1020279-2021-02630
• Device Sequence Number: 19648921
• Product Code: JWH
• UDI-Device Identifier: 00885556061794
• UDI-Public: 885556061794
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 10/27/2023
• Device Catalogue Number: 71933569
• Device Lot Number: 13KM21530B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: Required Intervention