MAUDE Adverse Event Report: ZIMMERBIOMET CHILE DFE ZIMMER BIOMET CRUCIATE STEM PUNCH; PUNCH, FEMORAL NECK

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2022

Event Type  Injury  

Event Description

Biomet tibial punch had a piece that broke off and was unknowingly left in the pt's knee.Immediate post op xr done, identified the foreign object and the pt went back to surgery to have the piece removed.Fda safety report id# (b)(4).

• Brand Name: ZIMMER BIOMET CRUCIATE STEM PUNCH
• Type of Device: PUNCH, FEMORAL NECK
• Manufacturer (Section D): ZIMMERBIOMET CHILE DFE
• MDR Report Key: 14592496
• MDR Text Key: 293363260
• Report Number: MW5110066
• Device Sequence Number: 1
• Product Code: HWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female