MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36MM X 29MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	DWD192
Medical Device Problem Codes	Unstable (1667); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient underwent right reverse shoulder replacement.Patient informed surgeon at the time that her right (prosthetic) shoulder was becoming more painful of late.X-rays / scans showed a loose glenoid component.During surgery of right prosthetic shoulder yesterday, thick blood-stained fluid aspirated from joint - possible infected joint, according to surgeon.Multiple tissue samples taken.Decision made to remove all components, except the well-fixed stem.All other components removed.Stem (left insitu) was converted to hemi-arthroplasty.2nd stage revision surgery will be planned for sometime in the future, when surgeon determines suitability.
Additional Manufacturer Narrative
Correction - d9 (product available to stryker).The reported event could be confirmed based on the medical expert opinion on the available x-ray record.A review of the x-rays by the medical expert stated the implant is used as intended and the glenoid implant is tilted superiorly indicating implant loosening.The reason behind the alleged failure is most likely infection.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.A review of the labeling did not indicate any abnormalities.Based on investigation and formal medical expert opinion the definitive root cause could not be attributed.The probable factor that led to loosening could be infection.If any further information is provided the complaint report will be updated.
Event or Problem Description
Patient underwent right reverse shoulder replacement.Patient informed surgeon at the time that her right (prosthetic) shoulder was becoming more painful of late.X-rays / scans showed a loose glenoid component.During surgery of right prosthetic shoulder yesterday, thick blood stained fluid aspirated from joint - possible infected joint, according to surgeon.Multiple tissue samples taken.Decision made to remove all components, except the well fixed stem.All other components removed.Stem (left insitu) was converted to hemi-arthroplasty.2nd stage revision surgery will be planned for sometime in the future, when surgeon determines suitability.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36MM X 29MM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 20707964
• Report Number: 3000931034-2024-00670
• Device Sequence Number: 8211961
• Product Code: KWS
• UDI-Device Identifier: 03700386935909
• UDI-Public: (01)03700386935909(11)210322(17)260322(21)0786AW020
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/22/2026
• Device Catalogue Number: DWD192
• Device Lot Number: 0786AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 84 KG