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

Catalog Number	550036000
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bone Notching (4890)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• 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: 50791964
• Report Number: 1818910-2026-15972
• Device Sequence Number: 16080995
• Product Code: HSD
• UDI-Device Identifier: 10603295546771
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550036000
• Device Lot Number: mi12449486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female