MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 {} RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420184
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed the patient experienced a loosening of the gns ii cmt tib size 4 {} right and a lgn cr high flex xlpe sz 1-2 9mm.This adverse event was resolved by revision surgery on (b)(6) 2023.The current health status of the patient in unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, in the absence of the requested information, clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond the reported loosening and revision of a the tibial baseplate and insert cannot be determined.No further medical assessment can be rendered at this time.Devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the tibial base plate, this failure mode will be monitored for future complaints for any necessary corrective actions.For the tibial insert a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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.
Event or Problem Description
It was reported that, after a tka surgery had been performed the patient experienced a loosening of the gns ii cmt tib size 4 {} right.This adverse event was resolved by revision surgery on (b)(6) 2023, where the lgn cr high flex xlpe sz 1-2 9mm and the gns ii cmt tib size 4 {} right were exchanged.The current health status of the patient in unknown.

• Brand Name: GNS II CMT TIB SIZE 4 {} RIGHT
• 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: 17986212
• Report Number: 1020279-2023-02029
• Device Sequence Number: 12861581
• Product Code: JWH
• UDI-Device Identifier: 03596010206343
• UDI-Public: 03596010206343
• 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 Explanted Year: 2023
• 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): 11/28/2023

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 Catalogue Number: 71420184
• Device Lot Number: UNKNOWN
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71453101/LGN CR HIGH FLEX XLPE SZ 1-2 9MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown