MAUDE Adverse Event Report: DePuy Ireland - 3015516266 INHANCE; Shoulder Implant - Glenosphere

Catalog Number	550536004
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the shoulder revised due to disassociated glenosphere.Stem was in varus position & explanted.During extraction, the shell / taper adapter became stuck on the star drive 30.The reporter were not able to get them separated.The glenosphere was not "lose at the bone to implant interface", the glenosphere was disassociated from the baseplate.There was no issue with the reverse liner.Doi: (b)(6) 2023 dor: (b)(6) 2026 affected side: right (b)(4) and (b)(4) are related.(b)(4) for the revision surgery due to disassociated.(b)(4) for during extraction, the shell / taper adapter became stuck on the star drive 30.
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.

• Brand Name: INHANCE
• Common Device Name: Shoulder Implant - Glenosphere
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50789982
• Report Number: 1818910-2026-15934
• Device Sequence Number: 13154171
• Product Code: HSD
• UDI-Device Identifier: 10603295546689
• UDI-Public: (01)10603295546689(17)280531(10)343268
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: 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: 550536004
• Device Lot Number: 343268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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 Sex: Unknown