MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 7; PROSTH,KNEE,PATFEMTIB,SEMICONSTR,CEMENT,POLY/MET/POLY

Model Number 74022227

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Infiltration into Tissue (1931); Toxemia (2207)

Event Date 01/05/2020

Event Type  Injury  

Event Description

It was reported that after an implantation procedure of a journey tibia base np lt sz 7, the patient presented a chrome intoxication.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 7
• Type of Device: PROSTH,KNEE,PATFEMTIB,SEMICONSTR,CEMENT,POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10789254
• MDR Text Key: 214722627
• Report Number: 1020279-2020-06186
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010554406
• UDI-Public: 03596010554406
• Combination Product (y/n): N
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 74022227
• Device Catalogue Number: 74022227
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other