MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 5 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71424005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient who underwent a left tka, reported continued pain with excessive noise (grinding/popping) while walking or laying down.The associated devices, used in treatment, were not returned for evaluation.Thus the product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.This reported failure has been identified in the instructions for use and risk management files as potential adverse events.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical evaluation noted the x-ray images provided do appear to have some osteolysis under the base plate and maybe a radiolucent line along the medial tibial stem but this would be best to be confirmed by the patient¿s surgeon with original quality images.It is advised that the patient consult with a surgeon on future steps to address their concerns.The patient has reported that no operative reports are available for inclusion of this investigation.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to traumatic injury, joint tightness, material in use or patient reaction (osteolysis).Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Event or Problem Description
It was reported that the patient had replacement surgery on (b)(6) of 2020.The unit of legion rk revision knee makes excessive noise (grinding/popping) when walking.The patient also has continuous pain/stiffness on the left side of the knee since the replacement surgery.The patient has been attending physical therapy 3 times per week and treating the pain with medication.There are no medical interventions done due to this issue.

• Brand Name: LGN REV TIBIA BASE SZ 5 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10145537
• Report Number: 1020279-2020-02331
• Device Sequence Number: 3220766
• Product Code: JWH
• UDI-Device Identifier: 03596010546098
• UDI-Public: 03596010546098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71424005
• Device Catalogue Number: 71424005
• Device Lot Number: 19BM02134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other