MAUDE Adverse Event Report: Tornier S.A.S. AEQUALIS REVERSED II COMBO 36/42 INSERT TH.+9MM; Shoulder prosthesis, reverse configuration

Catalog Number	DWD989
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient has re-presented to surgeon, following revision shoulder arthroplasty in (b)(6) 2026.Significant swelling and redness over wound, pain on movement.Wound re-opened, and surgeon concluded that the prosthetic joint was now infected.Decided to remove all prosthesis, as stage 1 of a 2-stage revision.Glenoid component was found to be very loose, easily removed as 1 x construct (revised at previous revision).Humeral component (not revised at previous revision) was found to be extremely well fixed.Humeral poly insert removed - significant wear noted (only been insitu since (b)(6) '26 revision).Proximal humeral vertical osteotomy was required to loosen and to break the bone / implant on growth.Stem eventually removed; osteotomy cabled back together with nice loops.Multiple tissue specimens collected; debridement; copious lavage attended; no antibiotic spacer implanted - gleno-humeral joint left dis-articulated.Plan - antibiotic regime until clinical markers indicate no infection, then the 2nd stage revision will be undertaken, using a "custom glenoid", to be manufactured by a competitor company.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: AEQUALIS REVERSED II COMBO 36/42 INSERT TH.+9MM
• Common Device Name: Shoulder prosthesis, reverse configuration
• Manufacturer (Section D): Tornier S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): Tornier S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50790675
• Report Number: 3000931034-2026-00691
• Device Sequence Number: 21475630
• Product Code: PHX
• UDI-Device Identifier: 03700386932748
• UDI-Public: 03700386932748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWD989
• Device Lot Number: 3015BB059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• 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 Sex: Male