MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL9MM; PRSTHSS,KNEE,FMOROTBAL,NN-CONSTRNED,CMNTD,METAL/POLYMER

Model Number 71422252

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported that patient had a breakage of the knee implant.Unknown if a revision surgery was performed already.

Manufacturer Narrative

After further review of the information provided it has been determined that this event is a duplicate of event reported under 1020279-2019-04201 , (b)(6).Hence this complaint will be closed and all further communications about this event will performed under 1020279-2019-04201.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/RL9MM
• Type of Device: PRSTHSS,KNEE,FMOROTBAL,NN-CONSTRNED,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9434003
• MDR Text Key: 169800398
• Report Number: 1020279-2019-04327
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582133
• UDI-Public: 03596010582133
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

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: 71422252
• Device Catalogue Number: 71422252
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention