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

Catalog Number UNKN01200300

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2021

Event Type  Injury  

Event Description

It was reported that, after a tka had been performed on an unspecified date, the post of a journey 1 bcs 7-8 right 11mm insert broke.A revision surgery was conducted to exchange it for a 13 mm journey revision insert.Current patient health status 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, the responses to clinical requests were not provided, therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported breakage.Based on the information provided, a revision surgery was performed to exchange the broken post of a journey 1 bcs 7-8 right 11mm insert for a 13mm journey revision insert.However, the patient impact beyond the reported event could not be determined based on the limited information provided.Therefore, no further clinical/medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and 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.

• Brand Name: UNKN JOURNEY 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: 12135720
• MDR Text Key: 260494707
• Report Number: 1020279-2021-05827
• 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
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention