MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW CR OXIN SZ 6N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Injury (2348)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2020 due to severe left knee stiffness and pain in the patient.The tibial insert was revised and explanted from the patient.The patient is still recovering from the surgery.Initial surgery in the left knee was performed on (b)(6) 2015.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Part number has been updated.
Additional Manufacturer Narrative
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 per complaint details, a revision of the lgn cr tibial insert was performed approximately 5.5yrs post implantation for a painful, stiff left total knee (ae#1).Per the sae crf, the pain and stiffness were ¿due to patient noncompliance to pt¿ per the surgeon, which does not suggest a mal-performance of the component.Based on the limited information provided in the crfs, the root cause of the event was reportedly the noncompliance with physical therapy.The patient impact beyond the reported pain, stiffness and subsequent revision could not be determined, although as of 9/10/2020 the patient outcome was ¿recovering/resolving¿.No further medical assessment is warranted at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes could be alignment, fit/size of device used or wear.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 NARROW CR OXIN SZ 6N LT
• 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: 10583539
• Report Number: 1020279-2020-04844
• Device Sequence Number: 11553723
• Product Code: JWH
• UDI-Device Identifier: 00885556233603
• UDI-Public: 00885556233603
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K112941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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: 71421246
• Device Catalogue Number: 71453183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 06/24/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/24/2020; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421246, 71420166, 71420576
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention