MAUDE Adverse Event Report: ZIMMER BIONET OXFORD UNICOMPARTMENTAL

Model Number 6195-1001

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); Joint Swelling (2356)

Event Date 11/14/2017

Event Type  Injury  

Event Description

I had experienced knee swelling and pain for about three years.I was always told that i needed more physical therapy and time by the orthopedic surgeon that operated on me (b)(6).I have moved to (b)(6).One morning i was unable to bear weight on my left knee.I set up an appointment with dr.(b)(6) at the (b)(6).I was examined by dr.(b)(6) and had an x-ray performed.Dr.(b)(6) determined that the zimmer biomet, oxford, partial knee replacement had failed.There is an unicondylar knee replacement with dissociation of the polyethylene insert.I am having full knee replacement surgery for my left knee on (b)(6) 2018 as a solution to the failed oxford knee replacement manufactured by zimmer-biomet.

• Brand Name: OXFORD UNICOMPARTMENTAL
• Type of Device: OXFORD UNICOMPARTMENTAL
• Manufacturer (Section D): ZIMMER BIONET
• MDR Report Key: 7457779
• MDR Text Key: 106620028
• Report Number: MW5076706
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6195-1001
• Device Catalogue Number: 154722
• Device Lot Number: 414950
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 109