MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP FEM SZ 3 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71423213
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery, both porous and non-porous components were prepared for the procedure, then, the customer mistook non-porous component for porous one, and the legion cr np fem size 3 right was implanted without bone cement.There was no surgical delay.No patient injuries or other complications were reported.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, both non-porous and porous components were prepared for the procedure and a non-porous component was inadvertently implanted without cement.It was communicated that the requested clinical documentation/information was not available for inclusion in the medical investigation.Per further correspondence, a revision was performed approximately 10 days later to explant the non-porous component and replace with a porous implant.The root cause of the reported event was the reported user/procedural variance as the customer ¿mistook non-porous component for porous one¿.The patient impact beyond the reported event, subsequent revision and an anticipated post-operative recovery phase could not be determined.No further assessment can be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.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.Possible probable cause could include but not limited to procedural variance or 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 CR NP FEM SZ 3 RT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11720938
• Report Number: 1020279-2021-03407
• Device Sequence Number: 3091877
• Product Code: JWH
• UDI-Device Identifier: 00885556029428
• UDI-Public: 00885556029428
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Model Number: 71423213
• Device Catalogue Number: 71423213
• Device Lot Number: 18DM16192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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; Other; Required Intervention