MAUDE Adverse Event Report: ZIMMER GEL-ONE

Lot Number 0016H05G

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Inflammation (1932)

Event Type  Injury  

Event Description

Dr.(b)(6) (radiologist, (b)(6)) stated that pt's whole hip got inflamed and enlarged, all the muscles around it got inflamed, she couldn't walk, she went to the hospital because of that, the culture from the soft tissue showed that there is staph aureus infection, she wanted to check that the med was contaminated, lot number is 0016h05g, expiration date 09/21/2017, (b)(4), pt is out of hospital now, she's on antibiotics.Strength: 30 mg/3 ml.Dose or amount: 30 mg, frequency: once, route: ia into right hip.Dates of use: (b)(6) 2016.Diagnosis or reason for use: unilateral primary osteoarthritis right hip.

• Brand Name: GEL-ONE
• Type of Device: GEL-ONE
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 6249112
• MDR Text Key: 64995719
• Report Number: MW5067199
• Device Sequence Number: 1
• Product Code: JDG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/21/2017
• Device Lot Number: 0016H05G
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization