MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK JUGGERKNOT 2.9MM; SPORTSMED, IMPLANTS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient underwent an initial procedure on an unknown date.Subsequently the patient underwent a revision of anchor due to pain and cyst formation on the olecranon event occurred years after surgery.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Review of the medical records identified that the patient was seen approximately 4 years post implantation, and was found to have significant inflammatory response, increased fluid/synovitis in the elbow, wider olecranon tunnels, extensive bone edema, partial tear on deep side the ucl insertion, and delineation.The patient did undergo a revision due to all of this.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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

No further event information available at the time of this report.

• Brand Name: UNK JUGGERKNOT 2.9MM
• Type of Device: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8830471
• MDR Text Key: 152312770
• Report Number: 0001825034-2019-03174
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 86