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 suffered from a postoperative infection.The customer asks is to check the lot regarding sterility.

Manufacturer Narrative

The associated journey uni tibial insert, journey uni cocr femoral component and journey uni tibial baseplate were not returned for evaluation.Our clinical analysis noted that no lab results or reports were provided to confirm the reported infection.Therefore a thorough medical assessment cannot be completed.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Products were sterilized according to sterilization release documentation from quality control.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved, 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 the devices 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: 8490063
• MDR Text Key: 141158193
• Report Number: 1020279-2019-01427
• 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: 07/31/2019

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: 17JBP0049A
• 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: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention