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

Model Number	725004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9788416
• Report Number: 1020279-2020-00781
• Device Sequence Number: 2778269
• Product Code: HSX
• UDI-Device Identifier: 03596010256805
• UDI-Public: 03596010256805
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K912735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 725004
• Device Catalogue Number: 725004
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR