MAUDE Adverse Event Report: ZIMMER, INC. GOLD TRIAL PIECE; PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)

Model Number 425170003-03

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

A piece of a total knee zimmeran gold trial device broke off.Fda safety report id# (b)(4).

• Brand Name: GOLD TRIAL PIECE
• Type of Device: PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 15249519
• MDR Text Key: 298402002
• Report Number: MW5111549
• Device Sequence Number: 1
• Product Code: HSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 425170003-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Female