MAUDE Adverse Event Report: EUFLEXXA; NONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Disability (2371); Ambulation Difficulties (2544)

Event Date 05/08/2014

Event Type  Injury  

Event Description

Ignoring that the damage to my knee was from an injury, not ra, dr.(b)(6) of (b)(6) hospital for special surgery injected euflexxa in (b)(6) of this year.I just had a tooth removed because the bone was being reabsorbed in a cyst that formed in may, below a microscopic crack that had healed in (b)(6).Subchondral marrow edema was mentioned in the mri report and the swelling has been replaced by rigidity.Motion is torturous, whereas i could walk before treatment.I wanted labral tears repaired and have been left more disabled.Even driving hurts, with every bump irritating swellings.Dose or amount: 3 injections; frequency: over 3 weeks; route: into knee, but it has tears.Dates of use: (b)(6)2014.Diagnosis or reason for use: knee vibrates if you flex while depressing patella.

• Brand Name: EUFLEXXA
• Type of Device: NONE
• MDR Report Key: 4031279
• MDR Text Key: 4846330
• Report Number: MW5037829
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/30/2015
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 82