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

Catalog Number	550001290
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had original surgery performed as a reverse total shoulder on (b)(6) 2024.Patient then had glenosphere fail and separate from the baseplate, leading to the second surgery performed on (b)(6) 2025.For that revision, surgeon only replaced the glenosphere and the humeral reverse liner.The patient then had their glenosphere fail again and separate from the baseplate.Surgeon revised again for a third case on (b)(6) 2026.Surgeon took everything out other than the humeral stem and replaced with depuy products.Doi: (b)(6) 2024.Dor: (b)(6) 2025.Affected side: right shoulder.This report captures the revision surgery performed on (b)(6) 2025, while related complaint (b)(4) captures the second revision surgery performed on (b)(6) 2026.
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 medwatch, a follow-up medwatch will be filed as appropriate.
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 performed.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.Corrected: d6a.
Additional Manufacturer Narrative
Product complaint: (b)(4).This record has been reviewed and it was confirmed (b)(4) is a duplicate from (b)(4).(b)(4) will be voided, and all further information will be handled under (b)(4).

• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24955953
• Report Number: 1818910-2026-07354
• Device Sequence Number: 10093305
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 06/12/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/29/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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; LOCKING SCREW 20; LOCKING SCREW 25; LOCKING SCREW 40; REVERSE HUMERAL SHELL XL 44+0; UNKNOWN SHOULDER GLENOSPHERE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male