MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027271
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to poly separation on post.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A clinical investigation concluded that this complaint reports a ¿poly separation on the post¿ of a journey ii bcs xlpe insert.The date of the primary surgery is not provided.After several attempts, no images or patient specific information has been provided.All documents and images, as of this date, have been reviewed by the clinical team.A lab analysis revealed significant deformation on the posterior surface of the ps post, which was likely caused by repeated contact with the femoral cam combined with excessive loads.Optical microscopy of the fracture surfaces revealed the presence of beach marks, which are typically formed due to the controlled growth of a fatigue crack.Based upon the presence and orientation of the beach marks, it appears that at least one fatigue crack initiated due to the damage on the posterior face of the ps post and propagated under cyclic loading in a generally anterior direction.These cracks likely propagated in this cyclic manner until the remaining material could not bear the imposed patient loading, which resulted in final fracture of the post.A review of complaint history did not reveal 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.No report on the patient¿s current status has been submitted at this time.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7379601
• Report Number: 1020279-2018-00679
• Device Sequence Number: 10983581
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: Lay User/Patient
• Device Catalogue Number: 74027271
• Device Lot Number: 17BM00528
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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