MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM FEM COMP; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

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

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was documented on the paper that the legion system (smith&nephew) was applied to 1 patient.The patient underwent a revision surgery due to metallosis.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the metallosis was confirmed.The clinical / medical investigation concluded that, per complaint details, the data presented in the article refers to a patient who required revision approximately 13 years post left tka due to a 6-month history of lle pain and swelling, laterally from knee to the ankle with onset of a ¿squeaking¿ with rom.Imaging within the article supported the complaint and the physician referenced in the abstract provided an analysis of all of the attached images; therefore, no further interpretation of the images are required.Reportedly, histology revealed necrosis and iron-stained macrophages consistent with hemorrhage and black-pigmented metal particles and the lle intraop exam of the fluid collection yielded black-pigmented tissue along the anterior compartment/extensor digitorum tendon and muscle.The article documented the patient ¿had no known injury to the leg but had fallen a few times without acute injury¿, and the pain started insidiously and progressing.The requested clinical documentation had not been received as of the date of this investigation, therefore further investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; however, the reported patient falls did not seem to be of interest in the article.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, implant corrosion or wear.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.

Event Description

It was reported in the publication "a unique case of extra-articular extravasation of metal into the lower leg resulting from oxidized zirconium wear particles from total knee arthroplasty" author: amanda purcell md.It was documented on the paper that the legion system (smith&nephew) was applied to 1 patients and underwent a re.

• Brand Name: UNKN LEGION TOTAL KNEE PRIM FEM COMP
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11072186
• MDR Text Key: 223606073
• Report Number: 1020279-2020-07778
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention