MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 6 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422346
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed since patient fell in (b)(6) 2018.
Additional Manufacturer Narrative
The associated juni oxinium femoral component, journey uni tibial baseplate and journey uni tibial insert were returned and evaluated.A lab analysis conducted during this investigation noted the femoral implant showed gouging along the articular surface.Damage is shown over the condylar surface.Slight damage shown on both sides of the implant, may have been caused by wear from third party particulates in vivo or by removal of the implant.Bone and/or bone cement was observed on the bone contacting surfaces and appeared well attached.The tibia insert showed gouging along the lateral side of the implant, which transitioned to a worn surface as the damage moved posteriorly.The sides of the insert also showed damaged material on the medial edge with deformation of the articular surface near the locking detail.The tibia baseplate showed damage along the locking detail and on the proximal surface of the baseplate.The bone-contacting surface of the baseplate damage showed burnishing and adherence of bone and/or bone cement to the surface.No material or manufacturing defects were observed in any of the components in the course of this investigation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical investigation noted that without supporting clinical/medical documents a thorough investigation cannot be performed at this time.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.Should additional information be received, the complaint will be reopened.

• Brand Name: JUNI OX FB FEM SZ 6 LM RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7808963
• Report Number: 1020279-2018-01615
• Device Sequence Number: 1573396
• Product Code: HSX
• UDI-Device Identifier: 03596010629777
• UDI-Public: 03596010629777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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 Expiration Date: 03/09/2024
• Device Catalogue Number: 71422346
• Device Lot Number: 14CM07832B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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; Required Intervention
• Patient Age: 71 YR