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

Catalog Number 71422366

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/13/2019

Event Type  Injury  

Event Description

It was reported that the patient has a postoperative infection.The customer wants to check the sterility of the device.

Manufacturer Narrative

The associated journey uni tibial basplate, journey uni tibial insert and journey uni cocr femoral component were not returned for evaluation.However, device details were provided.Thus, 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 the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Products were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.Our clinical evaluation could not be performed at this time as no clinical supporting documentation was provided.Should any relevant clinical information be provided this complaint will be re-evaluated.No further investigation 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.

• Brand Name: JUNI COCR FB FEM SZ 6 LM RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8490084
• MDR Text Key: 141160087
• Report Number: 1020279-2019-01429
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627490
• UDI-Public: 03596010627490
• Combination Product (y/n): N
• PMA/PMN Number: K073175
• 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: 06/05/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71422366
• Device Lot Number: 18FBP0003
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/07/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention