MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNAR COMPONENT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).Concomitant medical devices: nexel humeral component; unknown bearing.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent initial left total elbow arthroplasty.Subsequently, the patient underwent an additional procedure approximately 6 months post implantation.The patient then sustained a fall and was revised approximately one year post reimplantation due to implant and periprosthetic fracture.Another revision will occur when a custom ulnar component is available.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under 0001825034-2021-00649.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under 0001825034-2021-00649.

• Brand Name: UNKNOWN ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11087341
• MDR Text Key: 224088157
• Report Number: 0001822565-2020-04196
• Device Sequence Number: 1
• Product Code: JDC
• 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: 03/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention