MAUDE Adverse Event Report: EUFLEXXA SODIUM HYALURONATE

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Rash (2033); Chills (2191); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/16/2016

Event Type  Injury  

Event Description

After third injection of eufflexa had severe pain in left knee/joint, rash, chills, instability, trouble sleeping with severe pain.Pain was 4-5 on a scale of ten before injections.After injection, knee pain was a ten.I went to the emergency department as ordered by surgeon.They aspirated knee but could not get fluid.I was given a brace and pain medication.The severe pain (9-10) subsided (6-7) for about two weeks then reoccurred and the left knee has severe pain (10), instability, difficulty bearing weight on left leg, extreme pain at night while sleeping, occasional crepitus and cracking sounds from left knee, difficulty walking and difficulty with activities of daily living.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2016.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using the product: osteoarthritis.

• Brand Name: EUFLEXXA SODIUM HYALURONATE
• Type of Device: EUFLEXXA SODIUM HYALURONATE
• MDR Report Key: 6311728
• MDR Text Key: 66930128
• Report Number: MW5067754
• 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

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; GUAIFENESIN OCCASIONALLY; IBUPROFEN ; LORATADINE OCCASIONALLY; MELATONIN OCCASIONALLY; OTC MEDS:MULTIPLE VITAMINS; QVAR; RANITADINE; RX MEDS: LEVOTHYROXINE; SUBLINGUAL B COMPLEX; SUDAFED OCCASIONALLY; TYLENOL; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 82