MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID SIZER HANDLE; PROSTHESIS, SHOULDER, SEMI CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES

Catalog Number SBGL2000

Device Problem Fracture (1260)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while the instrument was being used by the surgeon the instrument fractured.There was no report of a foreign body being retained or any harm to the patient.Multiple attempts have been made to obtain additional information, but no additional information has been received at this time.

• Brand Name: GLENOID SIZER HANDLE
• Type of Device: PROSTHESIS, SHOULDER, SEMI CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18747865
• MDR Text Key: 335955932
• Report Number: 0001822565-2024-00632
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBGL2000
• Device Lot Number: 65003579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male