MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER

Model Number	71421509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in patient with patella degeneration due to patella arthritis.Insert was replaced and the patella resurfaced.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, and the reported event could not be confirmed.A review of the device history records for the reported batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical analysis indicated the x-rays provided confirm the report.Based on the information provided the pain, discomfort, and patella degeneration are likely due to the patella arthritis and not a mal-performance of the implant.The impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.The risk management file and instructions of use for the product were reviewed.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.If new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 11
• Common Device Name: PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9711279
• Report Number: 1020279-2020-00549
• Device Sequence Number: 11391169
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 03596010492364
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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 Expiration Date: 05/04/2024
• Device Model Number: 71421509
• Device Catalogue Number: 71421509
• Device Lot Number: 14EM05680
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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