MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 08/16/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain and insert wear.Genesis uni insert, genesis uni tibial base plate, and genesis uni femoral component were exchanged.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, it was reported that the insert revision was due to ¿pain and insert wear¿, which was believed to be due to ¿age related deterioration¿ and not component failure.The patient impact beyond the reported pain, insert wear and revision procedure could not be determined.Should patient specific clinical documentation become available in the future, the clinical/medical task may be re-evaluated at that time.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.

• Brand Name: KNEE IMPLANT
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9013116
• MDR Text Key: 158611621
• Report Number: 1020279-2019-03334
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GEN UNI INS,GEN UNI TIB BASE PLA,GEN UNI FEM COMP
• Patient Outcome(s): Hospitalization; Required Intervention