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

Catalog Number UNKN01200310

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2021

Event Type  Injury  

Event Description

It was reported that, after an unknown surgery, one (1) journey i or ii insert broke.This adverse event was solved by a revision surgery performed on (b)(6) 2021, in order to exchange the broken insert.Health status of patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, after three requests, no relevant supporting documents have been provided.Without the request clinical information a thorough medical investigation cannot be rendered nor can the root cause of the reported breakage be determined.Based on the limited information provided, to resolve this adverse event a revision was performed to exchange the broken insert.The impact to the patient beyond that which has already been reported is unknown.Should any additional medical information be provided, this compliant will 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 are not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.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.

• Brand Name: UNKN JOURNEY BCS / JOURNEY II BCS KNEE INSERT
• 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: 12211640
• MDR Text Key: 262938251
• Report Number: 1020279-2021-06028
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention