MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB XLPE INS SZ 1-2 8MM LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED,

Model Number	71935205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Metal Related Pathology (4530)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2020, a regular post operative assessment of the patient was performed.The patient was found with severe arthro-synovitis and a radiograph picture suggested probable metallosis and radio opaque deposits at the synovial level.A revision surgery was scheduled for urgent surgical cleaning and implant removal.On (b)(6) 2020, the revision surgery was performed to remove baker cyst and the implants, which were replaced with a mono-compartmental spacer with antibiotic-loaded cement.During surgery, an intracapsular metalogic synovitis (also near the baker cyst) was noticed.Also, the following implant failures were remarqued: degeneration of the polyethylene insert in the back side; consumption of the ceramic and metal coating below the distal region of the prosthetic femoral condyle; and consumption of the metal part in the back side of the tibial component.
Additional Manufacturer Narrative
Results of investigation: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the batch number.According to clinical/medical investigation , ¿severe arthro-synovitis¿ and albeit ¿difficult interpretation with probable metallosis and radiopaque deposits at the synovial level¿ was noted on x-ray during a regular post-op visit approximately 8 months post-implantation of a j-uni knee.Reportedly, an urgent ¿surgical cleaning¿, baker¿s cysts excision, and revision with 3-component-explantation/replacement with a mono-compartmental spacer with antibiotic-loaded cement was performed due to ¿suspected mechanical complications¿.Findings were listed as: ¿intracapsular metalogic synovitis with noted ¿degeneration of the polyethylene insert in the back side; consumption of the ceramic and metal coating below the distal region of the prosthetic femoral condyle; and consumption of the metal part in the back side of the tibial component.¿ the requested clinical documentation has not been provided as of the date of this assessment.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JII UNI TIB XLPE INS SZ 1-2 8MM LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10956376
• Report Number: 1020279-2020-07043
• Device Sequence Number: 3189553
• Product Code: HSX
• UDI-Device Identifier: 00885556578841
• UDI-Public: 00885556578841
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: Lay User/Patient
• Device Model Number: 71935205
• Device Catalogue Number: 71935205
• Device Lot Number: 18BAP0094D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71422342, LOT NUMBER 19MM06402; 71935194, LOT NUMBER 19DAP0189A
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR