MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ7 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, POLY/MET/POLY

Model Number 71421237

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that, after tkr surgery (legion cr with cori) had been performed on early 2022, the patient complained of instability in left knee from primary operation.After assessment of xrays, the surgeon suspects that the femoral component was oversized.This adverse event was treated by revision surgery to a more constrained construct.Current health status of patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Manufacturer Narrative

The device was not returned for evaluation.The pictures provided were reviewed and could not confirm the alleged instability nor the oversize issue., however the clinical/medical investigation concluded that based on the surgeon¿s statement, ¿it was one of the first cori cases that he had done, and believes the femoral component was oversized (after assessment of x-rays)¿.He also stated that he¿ suspected the patient had an issue with insufficient medial collateral ligament and lateral collateral ligament contributing to instability¿.The unlabeled, undated left lateral x-ray in figure 4, shows radiolucency under the tibial baseplate and around the stem and the appearance of femoral with radiolucency under the anterior and posterior portions consistent with the surgeon¿s analysis.The instructions for use does warn, ¿the appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone¿.Therefore, a procedural variance related to the selection and implantation of an oversized femoral component, radiolucency below the tibial baseplate, as well as the patient¿s history of insufficient medial collateral ligament and lateral collateral ligament cannot be ruled out as a contributory factors to the reported instability and resulting revision.According to the report, this adverse event was treated by revision surgery to a more constrained construct.Since the current health status of the patient is unknown, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that the correct selection of the implant has been identified in warnings and precautions.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors.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 file 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 product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, joint laxity, patient condition or postoperative care.The contribution of the device to the reported incident could be corroborated as it was required a revision surgery to treat this event.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: LEGION CR OXIN FEM SZ7 LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, POLY/MET/POLY
• 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: 15777595
• MDR Text Key: 303548236
• Report Number: 1020279-2022-04731
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556030486
• UDI-Public: 00885556030486
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71421237
• Device Catalogue Number: 71421237
• Device Lot Number: 21HM20026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2022
• Date Device Manufactured: 08/25/2021
• 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: 71420168/GNS II CMT TIB SIZE 5 {} LEFT; 71453121/LGN CR HIGH FLEX XLPE SZ 5-6 9MM; UNKN CORI DEV
• Patient Outcome(s): Other