MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML; PROSTHESIS, BIOLOGICS

Catalog Number 00111100100

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product device code - moz.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent a gel-one injection approximately seven (7) weeks ago.Subsequently, patient has not experienced relief since the procedure, and reported an increase of pain approximately five (5) weeks post-injection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that patient underwent gel one injection approximately two (2) months ago.Patient experienced pain after injection and doctor gave her a cortisone shot right after to alleviate the pain.Cortisone shot did not help and patient has been experiencing pain ever since.Patient called approximately three (3) weeks ago to report that her pain had gotten worse within the past 48 hours.Attempts have been made and no further information has been provided.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Type of Device: PROSTHESIS, BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo
• MDR Report Key: 12159692
• MDR Text Key: 261433129
• Report Number: 0001822565-2021-01923
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: Health Professional
• Device Catalogue Number: 00111100100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other