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

Catalog Number UNKN01200212

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

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032)

Event Date 08/18/2020

Event Type  Injury  

Event Description

On the literature article named "does the use of intraoperative pressure sensors for knee balancing in total knee arthroplasty improve clinical outcomes? a comparative study with a minimum two-year follow-up", it was reported that, 8 patients from the sensor balance group required manipulation under anesthesia due to stiffness.The outcome of the patients is unknown.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, in the data presented in the literature review, ¿a comparative study with a minimum two-year follow-up", it was reported that, 8 patients from the sensor balance group required manipulation under anesthesia due to stiffness.However, without clinically relevant patient-specific supporting documentation, a thorough medical 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; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of devices used or wear.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 devices 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, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12117000
• MDR Text Key: 260107169
• Report Number: 1020279-2021-05682
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• 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: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN LEGION TOTAL KNEE PRIM COUPLER; UNKN LEGION TOTAL KNEE PRIM STEM; UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE; UNKN LEGION TOTAL KNEE PRIM TIB INSERT XLPE
• Patient Outcome(s): Other