MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36MM X 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD182
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561); Insufficient Information (4580)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "reverse shoulder arthroplasty was performed for left shoulder of an 83 years old patient.After the surgery, the patient had not visited the hospital for a long time and follow-up investigation could not be performed all of that time.On (b)(6)2023, the patient visited and dislocation of the aequalis reversed glenosphere from the base plate was confirmed in the follow-up investigation.The revision surgery to replace the devices was performed on (b)(6) 2023.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.Devices were returned for evaluation and evidences were provided based on x-rays and reported data, which match the alleged failure mode.The devices inspection revealed the following: visually, the polished and flat surfaces of the sphere were completely found scratched, the central locking screw was found loose and deformed at the entry of the hexagonal footprint, and a material deformation was observed between the central screw and the nut inside the sphere.Functionally, the sphere could correctly impact and tighten into a baseplate-gauge (the baseplate left implanted in patient) with no issue to report.The baseplate/sphere assembly held very well.The issue described in the reported event is unable to be reproduced.Since images were provided, the opinion of a medical expert was sought and stated as following: "the x-rays confirm the event of the glenosphere being dislodged from the baseplate.The baseplate and humeral stem are well-positioned and well fixed"."the early postoperative image gives the impression that the glenosphere is well-positioned onto the baseplate"."(.) inferior border of the glenosphere is well below the inferior border of the glenoid as can be seen on the early postoperative x-ray.There is some pre-existing bone erosion at the inferior border of the glenoid already on the first postoperative x-ray, and it didn¿t change over time"."from the information at hand, a cause cannot be determined".Since images and implants were provided, the opinion of a r&d expert was also sought and stated as following: on the post-operative x-rays, the sphere has come completely out of the baseplate and the central screw of the sphere got stuck in the plastic insert.Moreover, as the sphere was dislocated, in this case the insert has come into contact with the baseplate and the sphere has come into contact with the baseplate.Glenoid components disassembly can be related to following reasons: either, a consequence of a surgical procedure: either the safety screw of the glenoid sphere was not properly tightened and/or the sphere-baseplate assembly was not impacted correctly (absence of peripheral groove around the baseplate, remaining soft tissues between the baseplate and the sphere), either, a consequence of a traumatic event, such as an improper motion.A review of the labeling did not indicate any abnormalities.The labeling states that: "to obtain good bone seating and secure fixation of the glenoid baseplate it is important to flatten the glenoid surface", "prior to positioning of the definitive glenoid sphere, it is important to remove any soft tissue between the baseplate and the glenoid sphere", "the fixation of the assembly is visually checked to ensure that no soft tissue is present between the baseplate and the glenoid sphere.Once impacted, secure the assembly by tightening the glenoid sphere screw", "finally, check that tightening is complete once the glenoid sphere is flush with the base plate".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "reverse shoulder arthroplasty was performed for left shoulder of an 83 years old patient.After the surgery, the patient had not visited the hospital for a long time and follow-up investigation could not be performed all of that time.On (b)(6) 2023, the patient visited and dislocation of the aequalis reversed glenosphere from the base plate was confirmed in the follow-up investigation.The revision surgery to replace the devices was performed on (b)(6) 2023.".

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36MM X 25MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18460107
• Report Number: 3000931034-2024-00004
• Device Sequence Number: 3100534
• Product Code: PHX
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• 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 Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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 Expiration Date: 09/03/2024
• Device Catalogue Number: DWD182
• Device Lot Number: 8407AU
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male