MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420580
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tkr surgery had been performed on (b)(6) 2019, the patient experienced knee pain.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Patient current health status is stable.
Additional Manufacturer Narrative
H3, h6.The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported knee pain cannot be definitively concluded.However, changes of the patella and how it is rotated and how it rides in trochlear groove and soft tissue irritation cannot be ruled out as a possible contributing factor to the patient¿s reported knee pain.The provided anteroposterior, lateral and sunrise x-ray imaging support the complaint.No additional radiologic imaging of the right knee was provided for comparison.Reportedly, the patella component was revised/explanted with all other knee components remaining in vivo.The patient impact is the reported pain and subsequent revision of the patella component.The patient¿s current health status is reportedly stable.Therefore, no further medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee system revealed that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants, this has been identified as warnings and precautions.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 26MM
• 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: 17466700
• Report Number: 1020279-2023-01549
• Device Sequence Number: 15230414
• Product Code: JWH
• UDI-Device Identifier: 03596010208323
• UDI-Public: 03596010208323
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 Catalogue Number: 71420580
• Device Lot Number: 18KM11657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/29/2023
• Date Device Manufactured: 10/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GII CR DEEP FLEX ISRT S3-4 9M, LOT#:15FM21342; GNS II CMT TIB SIZE 4 {} RIGHT, LOT#:18GT06846; LEGION CR NP FEM SZ 4 RT, LOT#: 18KM07987
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown