MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420962
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: case(b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6)2023, the patient experienced anterior tibial fracture.This adverse event was solved by a revision surgery on (b)(6)2023, in which tibial components were replaced while fixing the fracture.Health status of the patient is unknown.
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that although the provided x-ray images confirm the reported anterior tibial fracture, the images alone do not provide a clinical root cause.We cannot conclude if there was an intraoperative fracture that resulted in perforation from insertion that was not recognized and therefore a procedure error and/or bone quality issue that could result in a post operative fracture.Also the reason for the initial revision was not provided.Therefore, based on the limited information provided, it cannot be concluded that the fracture was related to a mal performance of the implants.The patient¿s activity level, trauma, or bone quality, which was not provided, cannot be ruled out as a contributing factor.The impact to the patient beyond the revision surgery cannot be determined.No further clinical/medical assessment is warranted at this time.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 systems revealed that tibia fractures could occur.This has been identified in possible adverse effects.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.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.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.H6: health effect - impact code.

• Brand Name: G2 CONST INSRT SZ1-2 13MM
• 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: 17075997
• Report Number: 1020279-2023-01241
• Device Sequence Number: 20543407
• Product Code: JWH
• UDI-Device Identifier: 03596010210111
• UDI-Public: 03596010210111
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420962
• Device Catalogue Number: 71420962
• Device Lot Number: D2207540
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: LGN OFFSET COUPLER 4MM, LOT#: 22ESM0276; LGN PRESSFIT STEM 10MM X 160MM, LOT#:17GSM0015A; LGN REV TIBIA BASE SZ 2 LT, LOT#: 23CM11312
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female