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

Model Number 74012831

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

It was reported that during a tka procedure the journey fem impl impactor broke inside of the patient.No pieces fell into the wound.All pieces were recovered.No surgical delay was reported but an s and n backup device was available.

• Brand Name: JOURNEY FEM IMPL IMPACTOR
• Type of Device: PROSTHESIS, KNEE, FMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9903121
• MDR Text Key: 185720714
• Report Number: 1020279-2020-01101
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556905
• UDI-Public: 03596010556905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012831
• Device Catalogue Number: 74012831
• Device Lot Number: 19FK00008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1