MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT18; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number 74023256

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/30/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain.Surgeon noticed that the poly being explanted was defective.

Manufacturer Narrative

The associated journey articular insert was returned and evaluated.A lab analysis conducted during this investigation noted that the post has fractured off; and the inferior edge at the anterior side of the insert has fractured also.The lock detail, the central notch posterior lock detail and internal notch lock detail on the device are deformed.However, there is no wear observed on the condylar articular surface of the part.The exact cause of the post fracture and other conditions mentioned could not be determined from the investigation of the device.There were no observations of material or manufacturing deviations in the course of this investigation.Our investigation including a review of review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation indicated that no clinically supportive documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 5-6 RT18
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/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
• MDR Report Key: 7591429
• MDR Text Key: 110747624
• Report Number: 1020279-2018-01107
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010555182
• UDI-Public: 03596010555182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2015
• Device Catalogue Number: 74023256
• Device Lot Number: 05MM11590
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention