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

Catalog Number	550000400
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
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).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.H11: additional manufacturer narrative: 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 during the normal process of the surgery, the size large short stem was implanted.The size large humeral shell and 36 +0mm retentive reverse liner were assembled on the back table and handed to the surgeon for implanting.The implant sizes and expiration dates were announced and agreed upon before opening.The surgeon placed the shell\liner assembly on the stem and immediately noticed the lack of contact between the shell¿s morse taper and stem.The surgeon removed the shell\liner assembly and checked for soft tissue interference.Both surfaces were clean and appeared normal.The sizes were once again confirmed and multiple attempts were made to place the shell\liner assembly on the stem, but the shell ¿bottomed out¿ before the taper engaged.There was a brief discussion to determine if the problem could be attributed to the stem or the shell.The surgeon made the decision to leave the stem in place and attempt another shell.A shell with the same part number but different lot was opened and temporarily placed on the stem for testing.The surgeon immediately noticed the feel of the proper engagement.A second liner was opened and assembled with the new shell on the back table.The shell\liner assembly was impacted on the stem and the morse taper held when tested by the surgeon.The entire experience added 12 minutes to the case.

• Brand Name: INHANCE
• Common Device Name: SHOULDER IMPLANT - HUMERAL HEAD
• 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: 24889217
• Report Number: 1818910-2026-06939
• Device Sequence Number: 21294899
• Product Code: PHX
• UDI-Device Identifier: 10603295546962
• UDI-Public: (01)10603295546962(10)665663
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550000400
• Device Lot Number: 665663
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male