MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM FEM COMP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a legion tka surgery, a revision was performed on (b)(6) 2024, due a ruptured patella tendon.The legion femur implant and cr insert were replaced with a legion revision femur and a high flex insert.Further information is unavailable.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this investigation, no additional supporting documentation has been received or made available for review.Therefore, a through medical investigation could not be rendered nor could a definitive clinical root cause of the reported patella tendon rupture be determined.According to the report, the legion femur implant and insert were replaced with a legion revision femur and a high flex insert.The impact to the patient beyond the reported patella tendon rupture and the reported revision cannot be determined since the patient¿s outcome is unknown.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the instructions for use documents for knee systems revealed in warnings and precautions, postoperative section that use extreme care in patient handling is needed and postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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.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 post-operative healing issue 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: UNKN LEGION TOTAL KNEE PRIM FEM COMP
• 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: 18767187
• MDR Text Key: 336109045
• Report Number: 1020279-2024-00425
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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?: 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: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• 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
• Patient Outcome(s): Required Intervention