MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to posterior knee pain.Further information is unknown yet.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.A lab analysis was conducted and confirms the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The tibial insert is still seated on the tibial baseplate and locked in place.The articulating surface of the insert has some wear present.Bone cement is still adhered to the bone cement contacting surface of the tibial baseplate.The periphery of the locking detail on the baseplate is scratched.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation was conducted and confirms no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Pain is potential complication associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8574044
• Report Number: 1020279-2019-01739
• Device Sequence Number: 2130888
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K951987
• 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): 02/28/2020

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: 71420164
• Device Catalogue Number: 71420164
• Device Lot Number: 18CT01550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 02/28/2020
• 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