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

Catalog Number	DWD182
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "surgery begins at the clinic for a review of total shoulder replacement.The surgery begins normally and it is planned to change the glenosphere and the insert.Once the glenosphere that the patient had is removed, the new medical device is circulated, once the central screw is going to be released it does not give movement, the specialist tries to release it and it is not possible.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9/h3.The reported event could be confirmed since the device was returned and was found to be in condition stated in the event description.The device inspection revealed the following: visually, the central safety screw was received stuck in the glenoid sphere.Probably due to several attempts to loosen the central safety screw during the surgery, the hexagonal footprint of the central safety screw was found slightly deformed, the central safety screw had important circular tool traces at the post level, and scratches and shocks traces were observed at the top of the sphere around the hole.After loosening the safety screw, the functionality of the glenoid sphere was checked, and it could correctly impact and tighten into the baseplate-gauge with no issue to report.The sphere was functional.The issue described in the reported event was unable to be reproduced.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.The labeling states that "when removing the sphere from its packaging, check the mobility of the central screw of the glenoid sphere by turning the screw clockwise when looking at the screw head (screwing-in direction)", "prior to positioning of the definitive glenoid sphere, it is important to remove any soft tissue between the baseplate and the glenoid sphere", "it is mandatory that the glenoid sphere is screwed manually", "particular cautions for the assembling of the glenoid sphere onto the glenoid baseplate: - first place the sphere in front of the baseplate, without screwing the central screw, - then impact the sphere onto the baseplate with the glenoid sphere impactor, - and finally secure the assembly by screwing the sphere central screw into the baseplate clockwise".No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "surgery begins at the clinic for a review of total shoulder replacement.The surgery begins normally and it is planned to change the glenosphere and the insert.Once the glenosphere that the patient had is removed, the new medical device is circulated, once the central screw is going to be released it does not give movement, the specialist tries to release it and it is not possible.".

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 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): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18065114
• Report Number: 3000931034-2023-00402
• Device Sequence Number: 20722128
• Product Code: KWS
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: DWD182
• Device Lot Number: 5176AY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 65 KG