MAUDE Adverse Event Report: (LEFT) TOTAL KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Granuloma (1876); Headache (1880); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Electrolyte Imbalance (2196); Blister (4537); Solid Tumour (4552)

Event Date 02/07/2015

Event Type  Injury  

Event Description

Admitted to hospital for suspected leg infection from a total knee replacement in the left leg.Vancomycin was given, 1000ml bag, was supposed to be given over a 24 hour period.The nurses administered 500ml in 15 minutes.Skin on the top of the left arm began to bubble with blisters, migraines started immediately.Infectious dr.Came in an laughed and said they administered it incorrectly.I have had nothing but problems afterwards.Diabetes, severe allergies, the sunlight instantly gives a burning sensation on the skin.Sarcoidosis is now present, which has caused kidney granuloma and bone granuloma, tumors.Reduced red blood cell production and hypercalcemia.Supposed total knee replacement infection affecting the leg.Reference report: mw5115577.

• Brand Name: (LEFT) TOTAL KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• MDR Report Key: 16512721
• MDR Text Key: 311061322
• Report Number: MW5115576
• Device Sequence Number: 1
• Product Code: JWH
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Patient Sequence Number: 1
• Treatment: VANCOMYCIN
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 101 KG