MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 INHANCE; SHOULDER IMPLANT - HUMERAL HEAD

Catalog Number	550000320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
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
(b)(6).Clinical adverse event received for non-displaced lesser tuberosity fracture on axillary view device related: possible procedure related: possible date of event: (b)(6) 2025 date of implant: (b)(6) 2025 date of revision: no information provided device location: left treatment/impact: observation depuy synthes products used: catalog number: 520002032 lot number: 58471 component type: stem description: inhance shoulder system standard stem small ø32mm x 109mm catalog number: 550300500 lot number: 230242 component type: screw description: inhance shoulder system self-drilling & locking screw 4 pack 20mm & 25mm catalog number: 550011240 lot number: 663948 component type: baseplate description: inhance shoulder system modular uniti platform baseplate small ø24mm cementless catalog number: 550035600 lot number: 226421 component type: screw description: inhance shoulder system central screw ø6.0 x 35mm catalog number: 550532004 lot number: 351203 component type: glenosphere description: inhance shoulder system glenosphere ø32+4mm catalog number: 550000320 lot number: 664124 component type: shell description: inhance shoulder system reverse humeral shell small ø32+0mm catalog number: 550032100 lot number: mi124845 component type: liner description: inhance shoulder system reverse liner retentive x-linked vitamin e pe ø32+0mm.
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.Added: d10 concomitant.

• 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 ; 9083863534
• MDR Report Key: 25314869
• Report Number: 1818910-2026-09329
• Device Sequence Number: 13246517
• Product Code: PHX
• UDI-Device Identifier: 10603295547006
• UDI-Public: (01)10603295547006(17)300228(10)664124
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550000320
• Device Lot Number: 664124
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: 4PK LOCKING SCRW 2025 SLFDRILL; CENTRAL SCREW 6.0X35; GLENOSPHERE 32+4; MOD UNITI CONV BASEPLATE S 24; REVERSE LINER 32+0 R; STANDARD STEM S 32
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female