MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS UNI FEMORAL LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, MTAL/POLYMR

Model Number 725004

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 01/31/2020

Event Type  Injury  

Event Description

It was reported that 17 years after primary surgery, revision surgery was performed due to non-traumatic breakage of the unicompartmental femoral component prosthesis.Tibial baseplate and insert were also explanted.

• Brand Name: GENESIS UNI FEMORAL LARGE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, MTAL/POLYMR
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9788416
• MDR Text Key: 182023779
• Report Number: 1020279-2020-00781
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010256805
• UDI-Public: 03596010256805
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 725004
• Device Catalogue Number: 725004
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR