MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER BIOMET PROXIMAL HUMERUS PLATE; PLATE, FIXATION, BONE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

On an unknow date, the patient underwent a revision procedure due to zimmer plate failure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ZIMMER BIOMET PROXIMAL HUMERUS PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17532140
• MDR Text Key: 321148513
• Report Number: MW5139048
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1