MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR SM; PROSTHESIS, SHOULDER

Catalog Number	110032410
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: comp rvs cntrl 6.5x20mm st/rst cat # 115394 lot # 67487234.Comp lk scr 3.5hex 4.75x20 st cat # 180551 lot # 67391387.Comp lk scr 3.5hex 4.75x25 st cat # 180552 lot # 67246545.Comp lk scr 3.5hex 4.75x15 st cat # 180550 lot # 67419841.Comp lk scr 3.5hex 4.75x15 st cat # 180550 lot # 67419841.G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient underwent a revision procedure approximately 5 days post implantation due to a poorly fixated and loosened central screw.The surgeon stated the central screw was too short and not bicortical, and accepted this as surgeon error.The surgeon also reported the patient had poor bone quality and avascular necrosis, which may have contributed to the failure, and was unsure if a longer bicortical central screw would have prevented the loosening failure.The patient was revised by removing the glenoid/baseplate and converting to a hemiarthroplasty.The humeral stem remained in situ.No additional patient outcome information was provided.Attempts have been made and no further information has been provided.
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, g3, g6, h2, h3, h6, h11.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is minimal purchase of the 2 inferior baseplate screws within the glenoid.Without intraoperative or immediate post-operative images, it cannot be determined if this superior inclination represents loosening of the glenoid baseplate or suboptimal positioning of the component.It was reported that the central screw was too short and was not bi-cortical.Per comprehensive reverse shoulder system surgical technique, there are three methods to determine proper central screw length.It was further reported that the patient had poor bone quality.Per ifu 01-50-0890, 'comprehensive® reverse shoulder screws' and ifu 01-50-1284 'comprehensive® reverse shoulder system augmented baseplates', 'humeral and glenosphere components should be used only when there is good quality bone.' the device history record was reviewed and no discrepancies relevant to the reported event were found.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: COMP AUG MINI BSPLT W TPR SM
• Common Device Name: 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: 24757190
• Report Number: 0001825034-2026-00805
• Device Sequence Number: 9138242
• Product Code: PHX
• UDI-Device Identifier: 00880304993235
• UDI-Public: (01)00880304993235(17)300613(10)67260159
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110032410
• Device Lot Number: 67260159
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female