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

Model Number 74012831

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure the plastic part of the jrny uni tibial impactor, journey fem impl impactor and a third impactor (unknown part) broke while being used inside the patient.There was no delay.Procedure concluded with the same device.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that only the uni tibia impactor, failed during the surgery, the other items are not presenting any malfunction nor caused any adverse event to report, therefore, it was determined that this case does not meet the threshold for reporting and complaint criteria, this is a non-reportable event.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: JOURNEY FEM IMPL IMPACTOR
• 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: 10854738
• MDR Text Key: 216766623
• Report Number: 1020279-2020-06546
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556905
• UDI-Public: 03596010556905
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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 Model Number: 74012831
• Device Catalogue Number: 74012831
• Device Lot Number: 06KM11651
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention