MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REVSD FRACTURE CONSTRAINED INSERT DIA36MM THCK+12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD972
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by the rep: "just wanted to make you aware of x4 implants in our loan kit for today that have all expired."patient under anaesthetic but no issues as implant sizes were not required.".
Additional Manufacturer Narrative
Corrected field: reporting contact (g1).The reported event could be confirmed, since the device was not returned for evaluation, however based on the provided evidence sterilization period expired could be confirmed.The device inspection was not possible as the product was not returned for investigation.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 as well as the affected device must be available in order to determine the root cause of the complaint event.However, a local nc has been opened to address the event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported by the rep: "just wanted to make you aware of x4 implants in our loan kit for today that have all expired."patient under anaesthetic but no issues as implant sizes were not required.".

• Brand Name: AEQ REVSD FRACTURE CONSTRAINED INSERT DIA36MM THCK+12MM
• 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): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21610035
• Report Number: 3000931034-2025-00130
• Device Sequence Number: 7756356
• Product Code: KWS
• UDI-Device Identifier: 03700386932618
• UDI-Public: (01)03700386932618(11)191114(17)241114(21)3058AV024
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Expiration Date: 11/14/2024
• Device Catalogue Number: DWD972
• Device Lot Number: 3058AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2019
• 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
• Patient Sex: Unknown