MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN JOURNEY BCS KNEE INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/26/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to the journey 1 std 9mm bcs insert broke during active labor of the patient.It is unknown the current status of the patient.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports the patient underwent a knee revision after the post broke on the insert, while the patient was in active labor.To date, the requested surgical reports and x-rays have not been provided.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN JOURNEY BCS KNEE INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10872187
• MDR Text Key: 217293057
• Report Number: 1020279-2020-06588
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K152726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention