MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 5 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422355
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the uni implants failed as per surgeon dr.(b)(6).Revision surgery performed to explant devices.Unable to see lots due to bone ingrowth.
Additional Manufacturer Narrative
The affected juni oxinium femoral component, journey uni tibial baseplate and journey uni tibial insert were returned and evaluated.From the analysis conducted during this investigation, the lab noted that the femoral implant showed bone and/or bone cement was observed on the bone contacting surfaces and appeared well-attached.Damage was observed along the rail of the cement pocket.Both sides of the articular surface also showed damage and gouged material on the articular surface.The insert had damage on the distal surface of the insert starting along the medial edge and moving anteriorly.It also showed wear along the articular surface with more damage near the anterior edge.The baseplate showed surface scratches along the proximal surface and edge of the baseplate.Burnishing was observed near the anterior side of the bone-contacting surface.No bone cement was visible on the bone-contacting surface.No material or manufacturing defects were observed in any of the components in the course of this investigation.A clinical evaluation noted that although the lab analysis reported poor bone attachment may have contributed to the loosening and subsequent failure of the device; there were no clinical supporting documents nor operative findings provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered due to the lack of relevant clinical documents.Only a review of the manufacturing records for the baseplate is possible as batch number for femoral component and insert is not legible.This review did not reveal any deviation from the standard manufacturing processes.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.

• Brand Name: JUNI OX FB FEM SZ 5 RM LL
• 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: 7971313
• Report Number: 1020279-2018-02171
• Device Sequence Number: 1572363
• Product Code: HSX
• UDI-Device Identifier: 03596010627414
• UDI-Public: 03596010627414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/18/2019

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 Catalogue Number: 71422355
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR