MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION TOTAL KNEE PRIM FEM COMP; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to the left knee failure, bad cement, and implant loosening.The patient outcome is unknown.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, a revision left tka was performed due to "bad cement and implant loosening".Reponses to medical documentation/clinical information requests were not received.Reportedly, the "bad cement" and loosening was the root cause of the reported event, although, this could not be definitively concluded based on the information provided.The patient impact beyond the reported loosening and revision could not be determined.Should additional clinical/medical information/documentation become available, the clinical/medical task may be re-opened for further evaluation.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN LEGION TOTAL KNEE PRIM FEM COMP
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10722850
• MDR Text Key: 212685356
• Report Number: 1020279-2020-05695
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN LGN PRM TIB BSPLT,UNKN LGN RSFCNG PAT CMP
• Patient Outcome(s): Hospitalization; Required Intervention