MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71421116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a knee surgery performed on (b)(6) 2010, the patient had a fall, so the doctor performed a revision surgery on (b)(6) 2022 to revise the gii oxin p/s fem right sz 6 for bone fracture.Patient current health status is unknown.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, after almost 13 years in-vivo, a knee revision was required due to a bone fracture secondary to patient fall.The complaint form indicates the femoral component and insert were revised.Although the fracture was reportedly directly related to the fall and led to the revision, supporting clinical documentation is not available per correspondence.Based on the limited information, no additional clinical factors could be concluded to have contributed to the reported event.The current patient status is unknown.Patient impact beyond the reported fracture secondary to the fall with subsequent revision could not be determined.No further medical assessment can be rendered at this time.Device 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.A review of the instructions for use documents for knee systems revealed in warnings and precautions, that the patient should be warned that the device does not replace normal healthy bone, and that long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Additionally, possible adverse effects section reveals that tibia, femur, or patella fractures can occur.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 product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury and/or patient bone quality.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 OXIN P/S FEM RIGHT SZ 6
• 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: 16092904
• MDR Text Key: 306588104
• Report Number: 1020279-2023-00021
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010469304
• UDI-Public: 03596010469304
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K962557
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71421116
• Device Catalogue Number: 71421116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• 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: GII PS INSERT SZ 3-4 15MM.
• Patient Outcome(s): Hospitalization; Required Intervention