MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNEE IMPACTOR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

During insertion/cementing of total knee components impactor instrument came apart in pieces and unable to find all the pieces.Surgeon, anesthesia, surgical team and sale rep aware of situation.Surgeon did a physical and visual inspection of open surgical wound and no pieces found.Or manager notified.Xray obtained prior to closure of wound without remark of retained object.

• Brand Name: KNEE IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 5400 meltech blvd ste 119; memphis TN 38118
• MDR Report Key: 15454374
• MDR Text Key: 300246178
• Report Number: 15454374
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female