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

Catalog Number UNKN01200212

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

Patient Problems Deformity/ Disfigurement (2360); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2021

Event Type  Injury  

Event Description

It was reported that on literature review ¿arthoplasty today 2021 - the oxinium arthrogram: a sign of oxidized zirconium implant failure¿, one adverse event was reported due to malalignment of the tibial component led to varus and excesive wear of the tibial poly insert and metal debris (black synovial fluids) while using unkn legion total knee prim fem comp component.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the malalignment was confirmed.The clinical/medical investigation concluded that, one adverse event was reported due to malalignment of the tibial component led to varus and excessive wear of the tibial poly insert and metal debris (black synovial fluids) while using unkn legion total knee prim fem comp component.However, s&n has not received the device, nor will clinically relevant patient-specific supporting documentation be provided; therefore, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided this complaint 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.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11736172
• MDR Text Key: 247667746
• Report Number: 1020279-2021-03599
• Device Sequence Number: 1
• Product Code: JWH
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention