MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74021165
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed for a xr total knee due to aseptic loosening of components.
Additional Manufacturer Narrative
The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Will proceed with a medical assessment based on clinical supporting documents provided.If no relevant medical information is provided can close the mi task.Approved by (b)(6), md a review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.

• Brand Name: JRNY II CR FEM OX NP LT SZ 5
• 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: 8334111
• Report Number: 1020279-2019-00546
• Device Sequence Number: 18846816
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• 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): 06/15/2019

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: Health Professional
• Device Catalogue Number: 74021165
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 06/15/2019
• 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