MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71421214

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, two hours after the patient had a right total knee replacement, it was realized that the sales rep covering had opened a left legion ps oxin fem sz4 and a left gns ii cmt tib size 2 instead of rights.The surgeon and or director were then notified of the mistake.The surgeon decided not to revise.The patient is progressing normally: has been released from physical therapy and is healing from surgery with no reported issues as of week 1 of 2024.

Manufacturer Narrative

Given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the documentation provided, human error led to the inadvertent implantation of left-sided components into the right knee, along with a non-recommended femoral and insert combination per the specification guide compatibility chart.It was noted in the electronic implant documentation record that a size 4 femoral component is implanted with a size 1-2 insert which is not recommended in the product specification guide compatibility chart.According with the total system specification guide and product catalog for legion total knee system, posterior stabilized size 1-2 inserts are only compatible with femoral components of sizes 1, 2 or 3.No clinical factors have been identified which would have contributed to the reported event.The patient impact includes the inadvertent implantation of contralateral components (left into a right knee) with a non-recommended femoral and insert combination and surgeon-recommended continued close monitoring with observation and evaluation of patella tracking and knee range of motion.Although no patient complaints of signs/symptoms of a mechanical nature have been reported, the construct may increase risks of patellar instability/dislocation, possible baseplate loosening, and/or insert wear; therefore, additional interventions and/or early revision cannot be ruled out.Further patient impact could not be determined.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the surgeon should be familiar with the technique and an adequate inventory of implant sizes should be available at the time of surgery.Additionally, revealed that the correct selection of the implant is extremely important.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The root cause of this event was determined to be human error.Based on this investigation, the need for corrective action is not indicated.Should 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.".

Event Description

It was reported that, two hours after the patient had a right total knee replacement, it was realized that the sales rep covering had opened a left legion ps oxin fem sz4 and a left gns ii cmt tib size 2 {} instead of rights.The surgeon and or director were then notified of the mistake.The surgeon decided not to revise.The patient is progressing normally: has been released from physical therapy and is healing from surgery with no reported issues as of week 1 of 2024.Patient reports a reduction in pain and improvement in mobility and knee range of motion.

• Brand Name: LEGION PS OXIN FEM SZ4 LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 18483704
• MDR Text Key: 332552735
• Report Number: 1020279-2024-00062
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556029121
• UDI-Public: 00885556029121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043440
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71421214
• Device Lot Number: 16FM03757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/15/2024; 02/13/2024
• Supplement Dates FDA Received: 01/30/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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
• Treatment: LGN XLPE PS INSERT SZ 1-2 13MM,GNS II CMT TIB SIZE.
• Patient Age: 60 YR
• Patient Sex: Female