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

Catalog Number UNKNOWN

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Guntin, j., bartosiak, k.A., della valle, c.J., patel, a., gerlinger, t.L., & nam, d.(2022).Radiographic and clinical analysis of a porous-coated metaphyseal cone for revision total knee arthroplasty.The knee, 37, 162-170.Doi.Org/10.1016/j.Knee.2022.04.003.

Event Description

It was reported that on literature review "radiographic and clinical analysis of a porous-coated metaphyseal cone for revision total knee arthroplasty", one (1) patient suffered from femoral component loosening after having a tka index revision surgery performed using legion metaphyseal cone system.This patient underwent an unspecified additional surgical intervention.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patient suffered from femoral component loosening after having an index revision tka surgery (without utilization of the femoral cone) and underwent an unspecified additional surgical intervention.The outcome of the patient is unknown.It was communicated that no further information is available.Without the requested clinical documentation, no clinical factors could be definitively concluded to have contributed to the reported events.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient impact beyond that which was reported could not be determined.No further medical assessment can be rendered 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.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, loss of ingrowth, osteolysis and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.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: UNKNOWN LEGION TOTAL KNEE REV FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 15684838
• MDR Text Key: 302563944
• Report Number: 1020279-2022-04597
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention