MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTED STEM 6.5MM X 100MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWB940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Joint Impingement (4834)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Revision of a 2009 reverse total shoulder replacement.Reason for revision was notching.Humeral component was loose.Components changed: glenosphere, humeral stem, uhmwpe liner.Single screw also removed from baseplate as notching from stem was hitting.
Event or Problem Description
Revision of a 2009 reverse total shoulder replacement at (b)(6) hospital by dr (b)(6).Reason for revision was notching.Humeral component was loose.Components changed: glenosphere, humeral stem, uhmwpe liner.Single screw also removed from baseplate as notching from stem was hitting.Additional information provided 3/6/25: due to the procedure being initially undertaken in 2009 i do not have the usage.I have a spreadsheet of usage from master dater.Believe it was the 2nd revision.No remarkable events, being revised due to notching/ metalosis.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.From the only provided picture taken in the operating room just after the devices explantation (soiled devices), we can observe that the removed peripheral screw was cut diagonally almost to the other extremity.Since the provided picture of the explanted devices was provided, the opinion of a r&d expert was sought and stated as follows: the notching on the screw is visible.It is probably at the spacer level that the friction with the screw occurred.Was the insert disassembled? a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.

• Brand Name: AEQUALIS REVERSED CEMENTED STEM 6.5MM X 100MM
• 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 NA ; EI NA
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22086965
• Report Number: 3000931034-2025-00294
• Device Sequence Number: 15468874
• Product Code: KWS
• UDI-Device Identifier: 03700386916175
• UDI-Public: 03700386916175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: DWB940
• Device Lot Number: UNKNOWN
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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 Age: 69 YR
• Patient Sex: Unknown