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
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.Surgeon noticed that the poly being explanted was defective.
Additional 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
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7591429
• Report Number: 1020279-2018-01107
• Device Sequence Number: 1698220
• Product Code: JWH
• UDI-Device Identifier: 03596010555182
• UDI-Public: 03596010555182
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2015
• Device Catalogue Number: 74023256
• Device Lot Number: 05MM11590
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention