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

Model Number	71420523
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	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a primary tkr case on the right side, surgeon tried to implant a size 3-4 9mm constrained liner and was unable to engage the poly, despite recommendations from the rep.Debris was cleared from the baseplate.Sizing compatibility was also checked and correct.Despite multiple attempts was unable to get the liner in.It was changed to posterior stabilized liner and there was no issues engaging the poly and surgeon was able to do so on first attempt.Surgery was not delayed more than 30 minutes.No other complication was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that surgeon tried to implant a size 3-4 9mm constrained liner and was unable to engage the poly.He changed to posterior stabilised liner and there was no issues engaging the poly and surgeon was able to do so on first attempt.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail.Scratches are observed on the surface of the device.A dimensional analysis was not performed as the damage/deformation at several features of the device would not allow for accurate measurement.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.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 or adverse event could not be corroborated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to size of device or surgical technique used.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LEGION CON ART INS 9MM SZ 3-4
• 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: 10624758
• Report Number: 1020279-2020-05153
• Device Sequence Number: 16753873
• Product Code: JWH
• UDI-Device Identifier: 03596010555823
• UDI-Public: 03596010555823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420523
• Device Catalogue Number: 71420523
• Device Lot Number: 17KT94017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 05/17/2021
• 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