MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT 9; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMER

Catalog Number	74023261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability.The journey insert was found broke.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A clinical investigation concluded that this complaint from (b)(6) is reporting the revision of a journey ii knee, secondary to instability.The primary surgery was performed in (b)(6) 2010.On (b)(6) 2017, the patient was lifting a heavy weight and felt something give in his knee.The insert post of the journey knee was found to be broken, resulting in the instability and requiring the revision.Based on results of the lab analysis, the likely cause of this fracture may have been due to repeated posterior impingement of the femoral cam on the ps post combined with excessive loads.The resultant damage on the posterior face of the ps post likely created a stress concentration that likely initiated one or more fatigue cracks, which propagated in an anterior direction until final fracture occurred.A review of complaint history revealed no additional complaints for the listed batch.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the very limited information, this adverse event appears to be the result of a trauma (heavy lifting) and not the fault of the prosthesis.No information on the patient¿s current status has been provided.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 LT 9
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7057939
• Report Number: 1020279-2017-01115
• Device Sequence Number: 18863542
• Product Code: JWH
• UDI-Device Identifier: 03596010555205
• UDI-Public: 03596010555205
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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 Catalogue Number: 74023261
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/24/2017
• Supplement Report FDA Received Date: 04/12/2018
• 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