MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420576
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).")).
Event or Problem Description
It was reported that after a right tkr surgery had been performed in 2013, the patient complained of patellar - femoral pain.A revision surgery was performed on (b)(6) 2023 in order to remove the gns ii resurf pat 32mm device and implant an oval 38mm resurfacing device.No further information available at this moment.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a patella resurfacing/revision was performed due to complaints of patellar-femoral pain approximately 10 years post implantation.Reportedly, a 38mm oval resurfacing component replaced the 32mm patellar component.As of the date of this medical investigation, no supporting clinical documentation has been provided; therefore, no clinical factors could be definitively concluded to have contributed to the reported event.Patient impact beyond the reported patella-femoral pain and subsequent patellar component revision/upsizing cannot be determined.The patient¿s current health status is unknown.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that the correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Generally, the largest cross-section component which will allow adequate bone support to be maintained is preferred.Also, periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone, this has been identified as warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 32MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16547326
• Report Number: 1020279-2023-00543
• Device Sequence Number: 14939057
• Product Code: JWH
• UDI-Device Identifier: 03596010208309
• UDI-Public: 03596010208309
• 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 Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 71420576
• Device Catalogue Number: 71420576
• Device Lot Number: 18JB00768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown