MAUDE Adverse Event Report: ZIMMER BIOMET / BIOMET, INC. OXFORD PARTIAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Model Number 159576

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Vision (2139); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Patient underwent a right knee oxford partial knee replacement on (b)(6) 2021 and began suffering reactions to it within 3 days post-operatively.Patient has experienced the following since the operation: bilateral hearing loss, vision loss, thyroid issues, muscle spasms, skin reactions, pain, fatigue, and swelling at the joint.

• Brand Name: OXFORD PARTIAL KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): ZIMMER BIOMET / BIOMET, INC.
• MDR Report Key: 16363465
• MDR Text Key: 309483989
• Report Number: MW5114875
• Device Sequence Number: 1
• Product Code: NRA
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 159576
• Device Catalogue Number: 159576
• Device Lot Number: 486170
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CYMBALTA 60 MG; RESTASIS EYE DROPS; SINGULAIR 10 MG; SYNTHROID 100 MG; VYVANSE 50 MG
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic