MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 LOCKING SCREW 35; SHOULDER IMPLANT - LOCKING SCREW

Catalog Number	550310035
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for implant shift device related: casual relationship (humeral stemless implant: yes) procedure related: possible date of event: 26 jan 2026 date of implant: (b)(6) 2025 date of revision: no information provided.Device location: right.Treatment/impact: observation.Depuy synthes products used: catalog number: 550011240 lot number: 66451 component type: baseplate description: enhance shoulder system modular unit platform baseplate small ø24mm cementless catalog number: 550035600 lot number: 237381 component type: screw description: enhance shoulder system central screw ø6.0 x 35mm catalog number: 550310035 lot number: 229426 component type: screw description: enhance shoulder system locking screw 35mm catalog number: 550310025 lot number: 233600 component type: screw description: enhance shoulder system locking screw 25mm catalog number: 550310035 lot number: 223956 component type: screw description: enhance shoulder system locking screw 35mm catalog number: 550540008 lot number: 333136 component type: glenosphere description: enhance shoulder system glenosphere ø40+8mm catalog number: 520000044 lot number: 659883 component type: humeral description: enhance shoulder system stemless x-large diameter 44mm cementless catalog number: 550000440 lot number: 659083 component type: shell description: enhance shoulder system reverse humeral shell x-large ø44+0mm catalog number: 550040104 lot number: mi124741 component type: liner description: enhance shoulder system reverse liner retentive x-linked vitamin e pe ø40+4mm.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform 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 = > there is no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LOCKING SCREW 35
• Common Device Name: SHOULDER IMPLANT - LOCKING SCREW
• 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: 24313129
• Report Number: 1818910-2026-02802
• Device Sequence Number: 5676200
• Product Code: HSD
• UDI-Device Identifier: 10603295546603
• UDI-Public: (01)10603295546603(17)300430(10)229426
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550310035
• Device Lot Number: 229426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2025
• 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: CENTRAL SCREW 6.0X35; GLENOSPHERE 40+8; LOCKING SCREW 25; LOCKING SCREW 35; MOD UNITI CONV BASEPLATE S 24; REVERSE HUMERAL SHELL XL 44+0; REVERSE LINER 40+4 R; STEMLESS XL 44
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White