MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE LINER 40+0; SHOULDER IMPLANT - HUMERAL CUP

Catalog Number	550040000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
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
Subject id: (b)(6), study no: (b)(6).Clinical adverse event received for right shoulder prosthetic joint dislocation device related: no information provided.Procedure related: no information provided.Date of event: 25 jun 2025.Date of implant: (b)(6) 2025.Date of revision: no information provided.Device location: right.Treatment/impact: shoulder reduction under sedation.Depuy synthes products used: catalog number: 550000440 lot number id: 663562 component type: shell device description: inhance shoulder system reverse humeral shell x-large ø44+0mm.Catalog number: 550011290 lot number id: 663627 component type: baseplate device description: inhance shoulder system modular uniti platform baseplate large ø29mm cementless.Catalog number: 550300500 lot number id: 229405 component type: screw device description: inhance shoulder system self-drilling & locking screw 4 pack 20mm & 25mm.Catalog number: 550040600 lot number id: 220792 component type: screw device description: inhance shoulder system central screw ø6.0 x 40mm.Catalog number: 550540008 lot number id: 351163 component type: glenosphere device description: inhance shoulder system glenosphere ø40+8mm.Catalog number: 520000044 lot number id: 200490 component type: humeral device description: inhance shoulder system stemless x-large diameter 44mm cementless.Catalog number: 550040000 lot number id: mi149641 component type: liner device description: inhance shoulder system reverse liner x-linked vitamin e pe ø40+0mm.
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 hat 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: added: b5 and d10.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
Additional information received: device related: not related.Procedure related: causal relationship.Treatment/impact: diagnostic intervention (labs, imaging, ecg), injected medication (etomidate, propofol, fentanyl, morphine, ondansetron, diphenhydramine, ketorolac, midazolam).A permanent impairment of a body structure or a body function: "yes".Outcome: "not recovered/not resolved".Is the adverse event serious? "yes".Does this adverse event meet the definition of a uade? "blank".
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: 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.
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: added: b5.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
Additional information received: clinical adverse event received for right shoulder prosthetic joint dislocation device and procedure(relatedness) device related: not related procedure related: causal relationship date of event: 24 jun 2025 date of implant: (b)(6) 2025 date of revision: no information provided device location: right.Treatment/impact: resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, labs, imaging, ecg, injected medication (etomidate, propofol, fentanyl, morphine, ondansetron, diphenhydramine, ketorolac, midazolam), non-surgical treatments (shoulder reduction under sedation), surgical intervention for the study shoulder, new components implanted (humeral polyethylene +4 mm retentive).

• Brand Name: REVERSE LINER 40+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: 22518741
• Report Number: 1818910-2025-12209
• Device Sequence Number: 21140158
• Product Code: PHX
• UDI-Device Identifier: 10603295546818
• UDI-Public: (01)10603295546818(17)281231(10)MI149641
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 550040000
• Device Lot Number: MI149641
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 07/24/2025; 07/31/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/22/2025; 07/25/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4PK LOCKING SCRW 2025 SLFDRILL.; CENTRAL SCREW 6.0X40.; GLENOSPHERE 40+8.; MOD UNITI CONV BASEPLATE L 29.; REVERSE HUMERAL SHELL XL 44+0.; STEMLESS XL 44.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male