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

Catalog Number	550001290
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2026
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
It was reported that glenosphere 40+8 failed and separated from the baseplate, resulting in the need for revision of a reverse total shoulder arthroplasty.The reported failure involved loosening of the glenosphere at the non-cemented interface, and the device was explanted and is available for return.The patient required corrective invasive procedures, including multiple revisions, but there were no adverse consequences reported as a result of these events.The complaint also involves modular uniti baseplate l 29, which was part of the revised construct.Other associated products, such as reverse liner 40+0 r, central screw 6.0 x 25, locking screw 40, locking screw 25, locking screw 20, and reverse humeral shell xl 44+0, were also explanted, but no patient consequences were reported for these components.Affected side: right shoulder.
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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that glenosphere failed and fell off of baseplate.Surgeon revised reverse tsa for second time.There was loosening of glenosphere at non-cemented interface.These are the explants from 2 previous cases done on this patient.First was done in (b)(6) 2024, second was done in (b)(6) 2025.The product was returned to depuy synthes for evaluation.The depuy synthes forwarded the complaint unit to the materials team for further analysis.The investigation revealed that the modular uniti baseplate l 29 was returned attached with its mating implant (glenosphere 40+8).Additionally, the baseplate presents bone ingrowth adhered to the fixation surface.The examination identified damage within the taper connection and adjacent surrounding areas.The observed taper damage is consistent with deformation and surface marking that can occur during in vivo service, surgical handling, and component removal.Based on the visual examination, the condition of the taper interface is not, by itself, indicative of a manufacturing nonconformance or a design-related deficiency.No visual evidence was identified to attribute the reported dissociation to a manufacturing defect or design flaw.The damage present on the taper and surrounding regions is most likely attributable to use-related and explantation-related effects rather than a product-related failure mechanism.Accordingly, based on the examination performed, the returned components do not exhibit findings that support a conclusion of manufacturing or design causation.A manufacturing record evaluation was performed for the finished device product description: modular uniti baseplate l 29, product code: 550001290, lot number: 659310 and no non-conformances nor manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the modular uniti baseplate l 29 would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product description: modular uniti baseplate l 29, product code: 550001290, lot number: 659310 and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: modular uniti baseplate l 29, product code: 550001290, lot number: 659310 and no non-conformances nor manufacturing irregularities were identified.Corrected: h3, h4.

• Brand Name: INHANCE
• Common Device Name: SHOULDER IMPLANT - BASEPLATE
• 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: 24872929
• Report Number: 1818910-2026-06813
• Device Sequence Number: 8951852
• Product Code: HSD
• UDI-Device Identifier: 10603295546627
• UDI-Public: (01)10603295546627(17)271031(10)659310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550001290
• Device Lot Number: 659310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 06/02/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/22/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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: CENTRAL SCREW 6.0X25; GLENOSPHERE 40+8; LOCKING SCREW 20; LOCKING SCREW 25; LOCKING SCREW 40; REVERSE HUMERAL SHELL XL 44+0; REVERSE LINER 40+0 R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male