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

Catalog Number	SBGL2000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in canada 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 glenoid sizer handle had split and would not hols the sizer into the handle.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g4; g6; h1; h2 if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the glenoid sizer handle had split and would not hold the sizer into the handle.The surgery was successfully completed with the device.The device broke at the end of the procedure.It was reported that no further information is available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Complaint can be confirmed through the returned product analysis.The tip of the device is damaged and deformed.Visual examination of the returned product identified signs of use as well as wear and tear.There are scratches on the handle of the device.Measured features of the handle to verify the sizer handle is conforming to print specifications.The device has a possible field age of 1+ years.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history identified additional similar complaints for the reported item and additional unrelated complaints for the reported and part and lot combination.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALLIANCE GLENOID SIZER HANDLE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 23638326
• Report Number: 0001822565-2025-04283
• Device Sequence Number: 9111975
• Product Code: KWS
• UDI-Device Identifier: 00889024574632
• UDI-Public: (01)00889024574632(11)240404(10)66396154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 66396154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 03/13/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/23/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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