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

Catalog Number	SBGL2000
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the inner capture of the glenoid sizer handle had worn away and broke while trying to attach it to the implant.The procedure was completed successfully with an alternate device and no patient harm was reported.Attempts have been made, and no further information has been provided.

• Brand Name: ALLIANCE GLENOID SIZER HANDLE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 24344672
• Report Number: 0001822565-2026-00519
• Device Sequence Number: 9423747
• Product Code: KWS
• UDI-Device Identifier: 00889024574632
• UDI-Public: (01)00889024574632(10)65579749
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SBGL2000
• Device Lot Number: 65579749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown