MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Sepsis (2067); Inadequate Osseointegration (2646)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a tka surgery had been performed in 2020, the patient underwent a different unrelated surgery which resulted in an infection, that subsequently spread to the knee.This caused the patient to experience implant loosening due to sepsis.This adverse event is being treated with a two-stage revision surgery.During the fisrt stage, performed on (b)(6) 2022, the three (3) legion primary implants were explanted.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided, this patient experienced implant loosening due to sepsis which resulted in a subsequent two-stage revision.Per report, during the 1st stage 3 legion primary implants were explanted.The impact to the patient beyond the reported loosening, sepsis and subsequent two-stage revision cannot be determined based on the information provided, therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include loss of sterility during procedure, patient reaction, bone degeneration, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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
• Type of Device: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• 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: 15318288
• MDR Text Key: 298869985
• Report Number: 1020279-2022-03875
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/29/2022
• 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