MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71423234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka, patient presented pain.A ct showed hot spots and loosening on tibial component and patella.A total knee revision surgery was performed to implant competitor's products.Patient outcome unknown.
Event or Problem Description
It was reported that after tka, patient presented pain and a total knee revision surgery was performed.Ct showed hot spots and loosening on tibial component and patella.Competitor's knee system was implanted.Patient outcome unknown.
Additional Manufacturer Narrative
It was reported that after tka, patient presented pain and a total knee revision surgery was performed.Ct showed hot spots and loosening on tibial component and patella.Competitor's knee system was implanted.Patient outcome unknown.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.So the reported event could not be confirmed.As device batch number was not provided, a review of the manufacturing records for the listed part could not be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 the instructions for use found that the reported failure was documented appropriately.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A medical analysis noted that the requested medical documentation was not available due to lack of consent.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, a thorough assessment cannot be rendered.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time, poor bone quality or patient medical history.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 PS NP FEM SZ 4 RT
• 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: 11086802
• Report Number: 1020279-2020-07860
• Device Sequence Number: 16971799
• Product Code: JWH
• UDI-Device Identifier: 00885556031049
• UDI-Public: 00885556031049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 71423234
• Device Catalogue Number: 71423234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/21/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR