MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	74022214
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to radiolucency in tibia.Metallosis and loose tibial base plate was identified.Femur was found solid but replaced since no tibial component was available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that insufficient clinically relevant information was provided to perform a thorough medical investigation.Therefore, no further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batch.Without the actual product involved and/or device information, our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 4
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7298274
• Report Number: 1020279-2018-00243
• Device Sequence Number: 1354925
• Product Code: JWH
• UDI-Device Identifier: 03596010554284
• UDI-Public: 03596010554284
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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 Expiration Date: 08/15/2021
• Device Catalogue Number: 74022214
• Device Lot Number: 11HM11443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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