MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

This case was received by zimmer biomet on (b)(6) 2017 from a patient.Manufacturer assured that there was no quality problem based on the manufacturing process, the in-process testing, the release testing and the environmental monitoring for lot no.0017e24g.(b)(4).

Event Description

On (b)(6) 2017- a (b)(6) year-old female patient received an injection of gel-one to the left knee for osteoarthritis.On (b)(6) 2017 - she had swelling, pain and couldn't walk.On (b)(6) 2017 - she didn't recover yet.The condition of her knee became so much worse than before.She thought she had to have a replacement.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo, oaza-aka; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept.; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 7027029
• MDR Text Key: 91901228
• Report Number: 9612392-2017-00012
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: H131001111001001
• UDI-Public: +H131001111001001/181860017E24GA05K
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017,10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0017E24G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 10/19/2017
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 71