MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027282
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient dislocated their jii knee.Surgeon fixed by using size 7/8 13mm constrained liner in place of the liner on complaint.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, slight scratches are shown along the articular surface of the implant, likely caused by in vivo wear of the material.Damage to the insertion/extraction slot was noted, which is likely a result of removing the implant.Little damage was seen on the locking detail and the distal faces of the tibia insert.Small amounts of wear are shown to the post of the tibia insert.No material or manufacturing defects were observed in the course of this investigation.A review of the production documentation for the corresponding products 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 batch.The clinical/medical team concluded, no supporting clinical/medical documents have been provided.Therefore a thorough medical investigation cannot be performed.The analysis of the returned explant indicated there are small slight scratches shown along the articular surface of the implant, likely caused by in vivo wear of the material.There was a small amount of damage seen on the locking detail and the distal faces of the tibia insert as well as small amounts of wear shown on the post of the tibia insert.Again, without radiological images (post primary and pre-revision, surgical/operative reports and other relevant medical information, a definitive root cause of the reported issue can not be determined from a clinical perspective.Additional or further risk to the patient beyond the revision cannot be concluded.No further medical assessment can be rendered based on the information provided.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM
• 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: 7435444
• Report Number: 1020279-2018-00765
• Device Sequence Number: 11117105
• Product Code: JWH
• UDI-Device Identifier: 00885556178362
• UDI-Public: 00885556178362
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2019

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: Lay User/Patient
• Device Catalogue Number: 74027282
• Device Lot Number: 17DM07962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018; 03/21/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/22/2018; 02/15/2019
• 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