MAUDE Adverse Event Report: DePuy Ireland - 3015516266 INHANCE; Shoulder Implant - Humeral Head

Catalog Number	550000408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Numbness (2415)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: dsm202108 clinical adverse event received for numbness in fingers following peripheral nerve block device related: not related procedure related: possible date of event: (b)(6) 2026 date of implant: (b)(6) 2026 date of revision: no information provided device location: left treatment/impact: observation depuy synthes products used: catalog number: 550515290 lot number: 666230 type: baseplate description: inhance shoulder system r/speed uniti platform baseplate large ø29mm cementless catalog number: 550300500 lot number: 240761 type: screw description: inhance shoulder system self-drilling & locking screw 4 pack 20mm & 25mm catalog number: 550540004 lot number: 357663 type: glenosphere description: inhance shoulder system glenosphere ø40+4mm catalog number: 520000040 lot number: 6642881 type: humeral description: inhance shoulder system stemless large diameter 40mm cementless catalog number: 550000408 lot number: 659079 type: shell description: inhance shoulder system reverse humeral shell large ø40+8mm catalog number: 550040000 lot number: mi134856 type: liner description: inhance shoulder system reverse liner x-linked vitamin e pe ø40+0mm.
Additional Manufacturer Narrative
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.

• Brand Name: INHANCE
• Common Device Name: Shoulder Implant - Humeral Head
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50589672
• Report Number: 1818910-2026-15159
• Device Sequence Number: 15815406
• Product Code: HSD
• UDI-Device Identifier: 10603295546979
• UDI-Public: (01)10603295546979(10)659079
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550000408
• Device Lot Number: 659079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male