MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the insert broke.
Additional Manufacturer Narrative
The associated journey bcs articular insert was not made available for evaluation.A thorough product evaluation could not be performed to determine the reason for the post breakage.However, pictures were provided and based on the provided pictures, the stated failure is confirmed.The insert post has broken off.Reasonable efforts to obtain the batch number have not been successful.Specific device details were not provided.Thus, a review of the manufacturing records could not be performed.Without the return of the actual product involved and as there is no batch information available, our investigation of this report is limited.As this device was implanted for 12 years, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that no relevant clinical/medical information was provided to conduct a thorough medical assessment.No further medical assessment can be rendered at this time.The device had been implanted for 12 years and a relationship, if any, between the devices and the reported incident could not be corroborated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: JOURN ART INS BCS STD 5-6 LT 9
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8329135
• Report Number: 1020279-2019-00527
• Device Sequence Number: 16701484
• Product Code: JWH
• UDI-Device Identifier: 03596010555205
• UDI-Public: 03596010555205
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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 Catalogue Number: 74023261
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1