MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 36+4; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550536004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for revision ¿ infection, device and procedure (relatedness), device related: no information provided, procedure related: no information provided, date of event: 8 jan 2026, date of implant: on (b)(6) 2025, date of revision: on (b)(6) 2026, device location: right, treatment/impact: components removed (cup), depuy synthes products used: catalog number: 550011240, lot number: 664514, component type: baseplate, description: modular uniti platform baseplate s 24, catalog number: 550030600, lot number: 227541, component type: screw, description: inhance central screw 6.0x30, catalog number: 550300500, lot number: 235418, component type: screw, description: inhance 4pk locking scrw 2025 slfdrill, catalog number: 550536004, lot number: 350285, component type: glenoid, description: inhance glenosphere 36+4, catalog number: 520001040, lot number: 664294, component type: stem, description: inhance short stem l 40, catalog number: 550000400, lot number: 664524, component type: shell, description: inhance reverse humeral shell l 40+0, catalog number: 550036104, lot number: mi125080, component type: liner, description: inhance reverse liner 36+4 r.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A search of the depuy synthes (nc) quality system found no nc¿s associated with this product/lot (product code: 550536004, lot - 350285) combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot- a search of the depuy synthes (nc) quality system found no nc¿s associated with this product/lot (product code: 550536004, lot - 350285) combination.Added: d10 (concomitant).

• Brand Name: GLENOSPHERE 36+4
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24233023
• Report Number: 1818910-2026-02099
• Device Sequence Number: 9221034
• Product Code: PHX
• UDI-Device Identifier: 10603295546689
• UDI-Public: (01)10603295546689(17)300228(10)350285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550536004
• Device Lot Number: 350285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4PK LOCKING SCRW 2025 SLFDRILL.; CENTRAL SCREW 6.0X30.; MOD UNITI CONV BASEPLATE S 24.; REVERSE HUMERAL SHELL L 40+0.; REVERSE LINER 36+4 R.; SHORT STEM L 40.; UNKNOWN SHOULDER IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male