MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM MICRO; PROSTHESIS, SHOULDER

Catalog Number 113612

Device Problem Difficult to Insert (1316)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that the surgeon was having issues with the implant not sitting on the bone.The surgeon re-surfaced the bone so it would sit without the gap.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).G2: foreign- australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP PRIMARY STEM 12MM MICRO
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18911660
• MDR Text Key: 337742470
• Report Number: 0001825034-2024-00659
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00887868267628
• UDI-Public: (01)00887868267628(17)330708(10)65886103
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113612
• Device Lot Number: 65886103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1