MAUDE Adverse Event Report: SMITH AND NEPHEW INC JOURN ART INS BCS STD 3-4 LT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023241
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery in which the bi-lateral patella was replaced.As a standard the surgeon does a poly change then as well.
Additional Manufacturer Narrative
The associated journey bcs articular insert was not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2008.A clinical analysis noted that no relevant documentation or information was provided, therefore a thorough medical investigation could not be performed.The patient impact beyond the expected post-op convalescence cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 3-4 LT 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7853095
• Report Number: 1020279-2018-01738
• Device Sequence Number: 19223801
• Product Code: JWH
• UDI-Device Identifier: 03596010555069
• UDI-Public: 03596010555069
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

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: 12/07/2018
• Device Catalogue Number: 74023241
• Device Lot Number: 08MM07904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 08/13/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 12/17/2018; 12/17/2018
• 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: Required Intervention