MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE LINER 36+0; SHOULDER IMPLANT - HUMERAL CUP

Catalog Number	550036000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189); Noise, Audible (3273)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for possible component dislocation, pt called office stating he was carrying an item down the hall and got caught on the corner and heard a pop and notices a clear bulge in his arm.Pt is headed to the ed and scheduled monday with dr.Device and procedure (relatedness).Device related: probable.Procedure related: causal relationship.Date of event: 12 dec 2025.Date of implant: (b)(6) 2025.Date of revision: no information provided.Device location: left.Treatment/impact: diagnostic intervention: yes (specify: xrays).Depuy synthes products used: catalog number: 550011240.Lot number: 664507.Component type: baseplate.Description: inhance shoulder system modular uniti platform baseplate small ø24mm cementless.Catalog number: 550300500.Lot number: 235422.Component type: screw.Description: inhance shoulder system self-drilling & locking screw 4 pack 20mm & 25mm.Catalog number: 550035600.Lot number: 232001.Component type: screw.Description: inhance shoulder system central screw ø6.0 x 35mm.Catalog number: 550536008.Lot number: 354226.Component type: glenosphere.Description: inhance shoulder system glenosphere ø36+8mm catalog number: 520002040.Lot number: 60051.Component type: stem.Description: inhance shoulder system standard stem large ø40mm x 121mm.Catalog number: 550000408.Lot number: 659079.Component type: shell.Description: inhance shoulder system reverse humeral shell large ø40+8mm.Catalog number: 550036000.Lot number: mi85583.Component type: liner.Description: inhance shoulder system reverse liner x-linked vitamin e pe ø36+0mm.
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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: 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.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.
Additional Manufacturer Narrative
Complaint record is approved to be converted to an npi on 23-feb-2026.There is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy synthes device after it was released for distribution.There is no report of an adverse event involving a depuy synthes device.Ae is noted to not be related to the device or procedure.Updates received: device related: not related.Procedure related: not related.Clinician review for conversion to npi complaint status: clinical site adverse event update notification has indicated that clinical site investigator has determined that with respect to the reported adverse event: the relationship to study device: not related the relationship to primary study procedure: not related does not meet the definition of a medical device complaint.Information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy device after it was released for distribution.There is no report of an adverse event involving a depuy device.Clinical study site indicates that the adverse event is not related to device or procedure.

• Brand Name: REVERSE LINER 36+0
• 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 ; 9083863534
• MDR Report Key: 23988438
• Report Number: 1818910-2026-00273
• Device Sequence Number: 4694759
• Product Code: PHX
• UDI-Device Identifier: 10603295546771
• UDI-Public: (01)10603295546771
• 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
• Device Explanted 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550036000
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White