MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TRIAL STEM 18 X 120; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434031
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while outside the patient, it was noticed that j-hook of a legion trial stem would not lock.A back up device was available to finish the case.No delay and no injury reported.
Additional Manufacturer Narrative
H3, h6: the device, intended for use 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 manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation 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 TRIAL STEM 18 X 120
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10235594
• Report Number: 1020279-2020-02667
• Device Sequence Number: 2425847
• Product Code: HRY
• UDI-Device Identifier: 03596010547606
• UDI-Public: 03596010547606
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2021

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: 71434031
• Device Catalogue Number: 71434031
• Device Lot Number: 06CM12496
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 06/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1