MAUDE Adverse Event Report: ZIMMER BIOMET RICCIONNE / ZIMMER, INC. GLENOSPHERE FORCEP; FORCEPS

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2022

Event Type  Injury  

Event Description

Patient with scheduled right reverse total shoulder arthroplasty.As part of care, a postoperative x-ray was completed and it revealed a foreign body.A piece of the inserter instrumentation, used to hold the prosthesis in place while screws are inserted, had broken off behind the ball joint portion of the shoulder implant.The patient returned to the operating room for removal of the foreign body.No harm to patient.Fda safety report id # (b)(4).

• Brand Name: GLENOSPHERE FORCEP
• Type of Device: FORCEPS
• Manufacturer (Section D): ZIMMER BIOMET RICCIONNE / ZIMMER, INC.
• MDR Report Key: 13659422
• MDR Text Key: 286566880
• Report Number: MW5107830
• Device Sequence Number: 1
• Product Code: HTD
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White