MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027222
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Insert was exchanged.Other components were retained.No more information reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.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 parts revealed no prior complaints for the listed batches/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM
• 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: 8534332
• Report Number: 1020279-2019-01607
• Device Sequence Number: 11373586
• Product Code: JWH
• UDI-Device Identifier: 00885556177266
• UDI-Public: 00885556177266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 74027222
• Device Lot Number: 17CM16118
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/21/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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