MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71420156

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Subluxation (4525)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, after right tka was performed in 2022, the patient noted that the femur would sublux from the tibia when doing a single leg squat and then rotating.The surgeon indicated this was a very unusual movement, for which a revision surgery was performed on (b)(6) 2023 implanting a legion hinge system to provide maximum stability.Patient is currently mobilizing well.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the reported patient activities (single leg squats), illicit drug use, and prior multi-ligament reconstruction (2022) all likely contributed to the event.The patient impact included the described ¿unusual movement¿ during single leg squat and rotating, likely secondary to the subluxation, in addition to the revision/conversion to a right total knee arthroplasty.A post-operative restorative phase would be anticipated.Further patient impact cannot be determined based on the information provided.Devices batch number were not provided, thus, an evaluation of the manufacturing records could not be performed.For the femoral component, base plate and insert, a review of complaint history for the part number over the past 12 months and for the 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 system revealed that dislocation 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 traumatic injury, patient condition or abnormal loading of limb.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: GII OXINIUM FEM SIZE 7 RIGHT
• Type of Device: 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: 18383599
• MDR Text Key: 331214744
• Report Number: 1020279-2023-02563
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010430816
• UDI-Public: 03596010430816
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71420156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GNSII CMT TIB SZ5 RT(PN:71420186); LGN CR FLX XLP SZ5-6 9MM(PN:71453121)
• Patient Outcome(s): Required Intervention; Hospitalization