MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION TOTAL KNEE PRIM TIB BASEPLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a tka was performed about 10 years ago, the patient experienced subsided and loosened of the tibia.Surgeon felt the heavy weight of the patient and a slightly oversized tibia caused the symptoms.This adverse event was treated by a revision surgery.Current health status of patient is unknown.

Manufacturer Narrative

B5 (event description update).

Event Description

It was reported that, after a tka was performed about 10 years ago with a legion system, the tibia subsided and loosened.It was the surgeon's opinion that the heavy weight of the patient and a slightly oversized tibia caused the incident.This adverse event was treated by a revision surgery.Patient is evolving normally.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, ten years post total knee arthroplasty implantation with a legion knee system, the patient had a revision total knee arthroplasty due to subsidence and loosening of the tibia.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.It has been noted within the e-mail correspondence within the attachments that no further information is available therefore, there were no clinical factors found which would have contributed to the reported event.However, it was reported that the surgeon¿s opinion that of the heavy weight of the patient and a slightly oversized tibia is what caused the reported event.The patient has been reported to be evolving normally.No further clinical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.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 abnormal motion over time, bone degeneration, patient condition and/or patient anatomy.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 LEGION TOTAL KNEE PRIM TIB BASEPLATE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16970544
• MDR Text Key: 315700309
• Report Number: 1020279-2023-01083
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2023
• 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?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Weight: 91 KG