MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported: "the initial surgery was performed on (b)(6) 2025, and on (b)(6) during a follow-up outpatient visit, the doctor confirmed that the patient had a dislocation.Since the dislocation was self-reduced, the patient was advised to wait and see, but since the patient requested a reoperation, a reoperation was scheduled for (b)(6).".
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was returned for evaluation with no evidence to confirm the event description, and no other evidences were provided.The device inspection revealed the following probably due to the insert and sphere extraction done by the medical staff, the parts were found significantly damaged and scratched.The insert is drilled in the middle, scratched at the smooth functional surface, with a groove noted on the flat edge and the ring outside of the insert groove.Due to the nature of the returned device, a dimensional and functional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: "the initial surgery was performed on (b)(6) 2025, and on (b)(6), during a follow-up outpatient visit, the doctor confirmed that the patient had a dislocation.Since the dislocation was self-reduced, the patient was advised to wait and see, but since the patient requested a reoperation, a reoperation was scheduled for (b)(6).".

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 36MM X 25MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork 38330 ; EI 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22440559
• Report Number: 3000931034-2025-00361
• Device Sequence Number: 14629896
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: (01)03700386935824(11)240524(17)290524(21)AH3056008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: DWD180
• Device Lot Number: AH3056
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male