MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN GENESIS II TOTAL KNEE PAT COMP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial mdr.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2022, the patient experienced osteonecrosis of an originally well placed unkn genesis ii total knee pat comp.This adverse event was solved by revision surgery on (b)(6) 2023.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-ray imaging appears to show patellar rupture/fracture with largest fragment riding laterally which is consistent with the reported osteonecrosis.It is unknown if the primary surgical technique was adhered to.Based on the limited documentation provided, further assessment cannot be performed.The patient impact included the radiological findings and the revision.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 systems revealed that periodic, long-term follow-up is recommended to monitor the condition of the adjoining bone.This has been identified in postoperative warnings and precautions.A review of the risk management file 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 this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, adverse reaction and/or bone quality.Based on this investigation, the need for corrective action is not indicated.Should the device 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: UNKNOWN GENESIS II TOTAL KNEE PAT COMP
• 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: 17167351
• Report Number: 1020279-2023-01344
• Device Sequence Number: 14889158
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown