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 Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
H6: the associated 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 part, probably from the attempted insertion.A dimensional evaluation was not performed as the damage/deformation at several features of the device would not allow for accurate measurement.The clinical/medical evaluation concluded that without the requested patient-specific clinical information/documentation, further assessment of the reported multiple attempts to engage two different right-sided constrained liners could not be performed.Reportedly, a ps liner implantation followed without complications; however, there was a 0-30-minute surgical delay.The product evaluation did confirm damage on the lock detail, although ¿the damage/deformation at several features of the device would not allow for accurate measurement¿ for a dimensional analysis.The clinical root cause could not be concluded.Patient impact beyond the reported 0-30-minute surgical delay could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential causes of the reported event could include but are not limited to size of device or surgical technique used.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 for future complaints and investigate as necessary.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: 10624760
• Report Number: 1020279-2020-05154
• Device Sequence Number: 11372365
• 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): 07/21/2021

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 Expiration Date: 07/27/2024
• Device Model Number: 71420523
• Device Catalogue Number: 71420523
• Device Lot Number: C1408957
• 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: 07/20/2021
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 07/21/2021
• 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