MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 5-6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had revision surgery on (b)(6) 2020, when a competitor's device was replaced with a s+n product.Another revision was performed on (b)(6) 2020, in which the poly insert was explanted and replaced because it was dissociated with the tibia base plate.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the device, used 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 medical investigation was conducted and confirms this case reports a revision was performed to exchange the poly insert, due to dissociation with the tibial baseplate.Per email communication, the requested surgical reports and x-rays are not available.Without supporting relevant documentation a thorough medical investigation cannot be performed.Therefore, the patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LEGION CON ART INS 9MM SZ 5-6
• 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: 10804388
• Report Number: 1020279-2020-06266
• Device Sequence Number: 3773371
• Product Code: JWH
• UDI-Device Identifier: 03596010555809
• UDI-Public: 03596010555809
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 71420537
• Device Catalogue Number: 71420537
• Device Lot Number: 17EM09186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 11/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FEM COMP, TIB BASEPLATE, STEM; FEM COMP, TIB BASEPLATE, STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention