MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TOTAL KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(6).

Event Description

It was reported that, after a tka surgery, the patient has broken his hinge mechanism twice, first time approximately after 4 years ((b)(6)), second time a few months after ((b)(6)).It is stated that the mechanism is now fused.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a patient with a history of malunion underwent a second revision due to the ¿patient has broken his hinge mechanism¿.Again within a few months¿.The requested medical documentation has not been received as of the date of this medical investigation and the current patient status other than it is ¿now fused¿ is unknown.Without the requested clinical documentation, the root cause of the reported events could not be further assessed.The patient impact beyond the reported broken hk mechanism with a recent history of malunion, subsequent revision which is ¿now fused¿ could not be determined.No further medical assessment could 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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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.Internal complaint reference number: case-2022-00105617-1.

• Brand Name: LEGION HINGE TOTAL KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED
• 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: 14556223
• MDR Text Key: 293074762
• Report Number: 1020279-2022-02714
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 06/30/2022
• 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; Other