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

Catalog Number UNKNOWN

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

Patient Problem Arthralgia (2355)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after tka surgery had been performed 12 years ago, on an unknown date, the patient experienced knee pain.A revision surgery was performed on (b)(6) 2023 to address this adverse event, changing the patella component.Current health status of patient is unknown.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that according to the report, the patient was revised 12 years post total knee arthroplasty on (b)(6) 2023, due to pain.It was reported the surgeon changed the patella component.Consequently, as of the date of this medical investigation, no new documentation has been provided; therefore, no clinical factors can be concluded to have definitively contributed to the patient¿s reported pain.The impact to the patient beyond the reported pain and subsequent revision cannot be confirmed nor concluded since the current health status of the patient is unknown.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions could not be performed.A review of the instructions for use documents for knee systems revealed in warnings and precautions that periodic, 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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, and/or patient condition.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 PATELLA COMPONENT
• 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: 18466016
• MDR Text Key: 332328306
• Report Number: 1020279-2024-00048
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/09/2024
• 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
• Patient Outcome(s): Required Intervention