MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient experienced pain.A revision surgery of left knee patella was performed to exchange the genesis ii biconvex patella 23mm.The patient outcome is unknown.
Additional Manufacturer Narrative
Results of investigation: it was reported that a revision surgery of left knee patella was performed due to knee pain.A genesis ii biconvex patella 23mm was removed and revised with a 29mm.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device batch information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to traumatic injury, joint tightness or patient reaction.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 23MM
• 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: 10301226
• Report Number: 1020279-2020-03381
• Device Sequence Number: 516155
• Product Code: JWH
• UDI-Device Identifier: 03596010208255
• UDI-Public: 03596010208255
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 71420566
• Device Catalogue Number: 71420566
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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