MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIGLIANI/FLATOW PEGGED GLENOID COMPONENT 46MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

It has been indicated that the product will not be returned to zimmer biomet for investigation, as the device was implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that during primary total shoulder arthroplasty, foreign particles were noted on the surface of the glenoid component when the packaging was opened.As no additional glenoid components were available, the implant was soaked in antibiotics and implanted.To date, this has not impacted the patient negatively following implantation and the surgeon does not plan to revise the component.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable.There are no allegations of failure of the device and the initial report was submitted in error.

Manufacturer Narrative

This supplemental report is being filed to relay additional information.

• Brand Name: BIGLIANI/FLATOW PEGGED GLENOID COMPONENT 46MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6883886
• MDR Text Key: 89253290
• Report Number: 0001822565-2017-06563
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00430204046
• Device Lot Number: 62959675
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1