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

Catalog Number	550032100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for closed nondisplaced fracture of acromial process of right scapula: device related: not related, procedure related: probable, date of event: 25 jul 2025, date of implant: on (b)(6) 2025, date of revision: no information provided, device location: right.Treatment/impact: other non-surgical treatments: yes (specify: sling with abduction pillow, ct scan with metal artifact reduction, components removed :humeral stemless implant: yes, reverse humeral shell: yes, reverse liner: yes, glenosphere: yes.Diagnostic intervention: (specify: ct scan with metal artifact reduction), other non-surgical treatments (specify: sling with abduction pillow).Resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function: yes.Surgical intervention for the study shoulder: yes.Staged revision: yes.Depuy synthes products used: catalog number: 520000040, lot number: 662039, component type: humeral, description: inhance shoulder system stemless large diameter 40mm cementless, catalog number: 550000400, lot number: 664523, component type: shell, description: inhance shoulder system reverse humeral shell large ø40+0mm, catalog number: 550032100, lot number: mi169614, component type: liner, description: inhance shoulder system reverse liner retentive x-linked vitamin e pe ø32+0mm, catalog number: 550532008, lot number: 345531, component type: glenosphere, description: inhance shoulder system glenosphere ø32+8mm.
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.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: 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 manufacturing records evaluation (mre) was not performed.

• Brand Name: INHANCE
• Common Device Name: Shoulder Implant - Humeral Cup
• 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: 50121933
• Report Number: 1818910-2026-13232
• Device Sequence Number: 10078302
• Product Code: HSD
• UDI-Device Identifier: 10603295546740
• UDI-Public: (01)10603295546740(17)290731(10)MI169614
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial

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: 550032100
• Device Lot Number: MI169614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 178 LB
• Patient Race: White