MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 3-4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number	71420523
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a revision surgery of legion primary cr prosthesis, when trying to exchange inlay, a genesis ii ps insert sz 3-4 11mm was used, but it could not be fixed on the tibial base.Then, it was attempted to anchor a legion con articular insert 9mm sz 3-4 and it also failed.The inlay could not be fixed and the procedure was finished using the same inlay in the patient.This issue caused a delay greater than 30 minutes.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device has minor damage more than likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have 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 a fit/ sizing issue or poor insertion technique.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.H6: code update.

• Brand Name: LEGION CON ART INS 9MM SZ 3-4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11001966
• Report Number: 1020279-2020-07398
• Device Sequence Number: 13625898
• Product Code: JWH
• UDI-Device Identifier: 03596010555823
• UDI-Public: 03596010555823
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/08/2021

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: 71420523
• Device Catalogue Number: 71420523
• Device Lot Number: C2003489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 09/08/2021
• 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: Hospitalization