MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE LINER 36+0; SHOULDER IMPLANT - HUMERAL CUP

Catalog Number	550036000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: dsm202108.Clinical adverse event received for possible infection of right shoulder incision device and procedure (relatedness), device related: not related, procedure related: possible, date of event: 29 dec 2025, date of implant: (b)(6) 2025, date of revision: no information provided, device location: right.Treatment/impact: hospitalization, diagnostic intervention (venous duplex, ultrasound, mri, xray), injected medication (vancomycin ivpb 2000mg, piperacillin-tazobactam iv 4.5mg), oral/topical medication (lidocaine 5% patch, acetaminophen-codeine 300-30mg, po linezolid 600 bid and augmentin 875 bid x 1 week).
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 medwatch, a follow-up medwatch will be filed as appropriate.
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 nonconformance (nc) quality system found no nc¿s associated with this product<550036000>/lot 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 nonconformance (nc) quality system found no nc¿s associated with this product<550036000>/lot combination.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d10 concomitant.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: REVERSE LINER 36+0
• Common Device Name: SHOULDER IMPLANT - HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24073142
• Report Number: 1818910-2026-00863
• Device Sequence Number: 21177353
• Product Code: PHX
• UDI-Device Identifier: 10603295546771
• UDI-Public: (01)10603295546771(17)290630(10)MI156850
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 550036000
• Device Lot Number: MI156850
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/22/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/22/2026; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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 6.0X35.; GLENOSPHERE 36+8.; MOD UNITI CONV BASEPLATE S 24.; REVERSE HUMERAL SHELL M 36+8.; STEMLESS M 36.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White