MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200301

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported that a after a tka surgery, a patient had four revision surgeries.The 3rd revision surgery was due to the tip of the journey i bcs tibial post that broke off.The date of this revision surgery and the outcome of the patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint, it was reported this patient required a 3rd revision surgery due to the tip breakage of the journey i bcs tibial post.However, per subsequent e-mail, the broken parts were given to the surgeon.Consequently, without the requested clinical information, implantation/revision operative reports, pre/post implantation radiographs the root cause of the reported tip breakage cannot be determined.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this compliant would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.It has been confirmed that the same event has been already reported under report number (b)(4) our internal reference number (b)(4)).We conclude that the event will be investigated under this last complaint mentioned.Therefore, this report will be closed as duplicate.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: UNKN JOURNEY / JOURNEY II KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12129412
• MDR Text Key: 260299533
• Report Number: 1020279-2021-05777
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 08/18/2021
• Supplement Dates FDA Received: 08/13/2021; 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention