MAUDE Adverse Event Report: Zimmer Biomet, Inc. Alliance®; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	SBGL2000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw disengaged from the blue vault guide handle while the instrument was being used as a glenoid targeting guide, and a second handle was obtained to continue the procedure.During cleaning after the procedure, the screw, which had been safely retained from the patient and operative site, was subsequently lost in the washer.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) the complaint can be confirmed through the returned product analysis.Fracture analysis has been previously analyzed for this fracture location where overload was identified as the mode of failure.Visual examination of returned product identified signs of use as well as wear and tear.The handle of the device has some knicks and wear marks from use.The body of the sizer handle has some scratches as well.The tip of the device is slightly deformed, and the plunger tip has fractured from the shaft.The fractured plunger tip was not returned with the device.The device history record was reviewed and no discrepancies relevant to the reported event were found.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®
• 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 ; +1(574)526-0384
• MDR Report Key: 50532281
• Report Number: 0001822565-2026-03012
• Device Sequence Number: 9910743
• Product Code: KWS
• UDI-Device Identifier: 00889024574632
• UDI-Public: (01)00889024574632(10)65092374
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 65092374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2026
• 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: 08/31/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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