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

Catalog Number	74022224
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening of the tibial baseplate.
Additional Manufacturer Narrative
The associated complaint devices were 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 review of complaint history did not reveal additional complaints for the listed batches.No clinical information has been provided for inclusion in this investigation.Therefore, without the requested supporting clinical/medical documents a thorough investigation cannot be performed.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 4
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8194119
• Report Number: 1020279-2018-02884
• Device Sequence Number: 2792724
• Product Code: JWH
• UDI-Device Identifier: 03596010554321
• UDI-Public: 03596010554321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• 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): 03/21/2019

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 Expiration Date: 05/17/2026
• Device Catalogue Number: 74022224
• Device Lot Number: 16EM15892
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY II INSERT (PN: 74027241/BN: 14AM12806); JOURNEY II INSERT (PN: 74027241/BN: 14AM12806)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention