MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 6; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/METAL/POLYMER

Catalog Number	74022226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening.
Additional Manufacturer Narrative
The affected journey tibial baseplate was not returned for evaluation.A clinical evaluation noted no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the manufacturing records for the listed batch 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.Without the actual product involved, our investigation of this report is inconclusive.Should the device or additional information be received in the future, the complaint will be reopened.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 6
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7375015
• Report Number: 1020279-2018-00615
• Device Sequence Number: 1092714
• Product Code: JWH
• UDI-Device Identifier: 03596010554345
• UDI-Public: 03596010554345
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: 12/07/2019
• Device Catalogue Number: 74022226
• Device Lot Number: 09MM05762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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