MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422223

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 05/16/2017

Event Type  Injury  

Event Description

It was reported that patient underwent a revision surgery with all components of journey deuce knee revised due to tibial loosening.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.Please see attached for investigation results.(b)(4).

• Brand Name: JOURNEY UNI TIB BASE LM/RL SZ 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6642661
• MDR Text Key: 77604123
• Report Number: 1020279-2017-00427
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422223
• Device Catalogue Number: 71422223
• Device Lot Number: 07DM01728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEUCE FEM OXZR SZ 4 LT, (B)(4); GNS II RESURF PAT 29MM, (B)(4); JRNY UNI TIBINRT S3-4LM/RL8MM, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR