MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420006
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a follow up examination 2 years after a tka surgery, the patient was diagnosed with metal allergy; the condition had been ongoing for the last year.To counter this adverse condition medication was prescribed on (b)(6)2023.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that it is undisclosed if the patient had known pre-existing allergies and no metal testing results have been provided.The root cause of the reported allergic reaction with itching and rash could not be definitively concluded as the information provided is insufficient to determine whether the patient¿s symptoms, signs and/or outcomes are due to a pre-existing or concurrent medical condition, concurrent adjunctive therapy/treatment, or due to an adverse reaction to a s+n component and/or surgical practice within this particular facility.Additionally, it was noted that the reported implanted combination of the gns ii c/r fem size 4 left and the gii dished ins size 1-2 9mm is not recommended/not compatible.It is unknown to what extent, if any, that this non-compatible combination contributed to the reported event.Based on the provided photos and prescription, the patient impact in the presence of an incompatible implant combination included the appearance of left lower extremity hyperpigmentation along with suspected itching and pain for which medication was prescribed.Further patient impact could not be determined.No further medical assessment can be rendered at this time.A review of the production order for the femoral component did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the tibial baseplate and insert, devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.For the femoral component's batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that although rare, metal sensitivity or allergic reactions in patients following joint replacement have been reported.Implantation of foreign material in tissues can result in histological reactions.This has been identified as a possible adverse effect.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 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 C/R FEM SIZE 4 LEFT
• 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: 17322416
• Report Number: 1020279-2023-01449
• Device Sequence Number: 5523621
• Product Code: JWH
• UDI-Device Identifier: 03596010205445
• UDI-Public: 03596010205445
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 71420006
• Device Catalogue Number: 71420006
• Device Lot Number: 21BM14092
• 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: 06/24/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2021
• 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: 71420754/GII DISHED INS SZ1-2 9MM; 71422692/ANTHEM TIBIAL BASE PLATE SZ 2 LT
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG